clinical phase iii product report - cbdmt market and business intelligence - toc

Clinical Phase III Product Report

Author: Philippe Tramoy

Date: 20 September 2010

“Copyright 2010 CBDM.T SARL - Market and Business Intelligence. All rights reserved. Any unauthorized use or disclosure is

prohibited. The information herein was obtained from various sources; we do not guarantee its accuracy or completeness.

This research report is prepared for general circulation and is circulated for general information only. It does not have

regard to specific investment objectives, financial situation and the particular needs of any particular person who may

receive this report. Investors should seek financial advice regarding the appropriateness of investing in any securities or

investment and trading strategies discussed or recommended in this report and should understand that the statements

regarding future prospects may not be realized. Investors should note that income from such securities, if any, may

fluctuate and that each security's price or value may rise or fall. Accordingly, investors may receive back less than originally

invested. Past performance is not necessarily a guide to future performance. Neither the information nor any opinion

expressed constitutes an offer to buy or sell any securities or options or futures contracts. CBDM.T - Market and Business

Intelligence accepts no responsibility or liability whatsoever for any expense, loss or damages arising out of or in any way

connected with the use of all or any part of this report. CBDM.T SARL does not have long or short position in any securities

or options of this issue(s)."

CBDM.T® - Market & Business Intelligence © 2010 1/1749

Table of Content

1) (R)-FLURBIPROFEN .................................................................................................................. 102

Summary ......................................................................................................................................... 102

Originators ....................................................................................................................................... 102

Licensing and General info: ............................................................................................................. 102

Clinical Data: .................................................................................................................................... 102

2) 13-CIS-RETINOIC ACID ............................................................................................................. 104

Summary ......................................................................................................................................... 104

Originators ....................................................................................................................................... 104


Clinical Data: .................................................................................................................................... 105

3) 166HO-PHYTATE ...................................................................................................................... 107

Summary ......................................................................................................................................... 107

Originators ....................................................................................................................................... 107


Clinical Data: .................................................................................................................................... 107

4) 2-PX .......................................................................................................................................... 109

Summary ......................................................................................................................................... 109

Originators ....................................................................................................................................... 109


Clinical Data: .................................................................................................................................... 110

5) AB-1001 ................................................................................................................................... 112

Summary ......................................................................................................................................... 112

Originators ....................................................................................................................................... 112


Clinical Data: .................................................................................................................................... 112

6) ABIRATERONE ACETATE .......................................................................................................... 114

Summary ......................................................................................................................................... 114


Originators ....................................................................................................................................... 114


Clinical Data: .................................................................................................................................... 114

7) ACADESINE .............................................................................................................................. 116

Summary ......................................................................................................................................... 117

Originators ....................................................................................................................................... 117


Clinical Data: .................................................................................................................................... 117

8) ACETAMINOPHEN + TRAMADOL HYDROCHLORIDE ................................................................ 119

Summary ......................................................................................................................................... 119

Originators ....................................................................................................................................... 119


Clinical Data: .................................................................................................................................... 119

9) ACETYLCHOLINESTERASE INHIBITOR (PFIZER) ........................................................................ 121

Summary ......................................................................................................................................... 121

Originators ....................................................................................................................................... 122


Clinical Data: .................................................................................................................................... 122

10) ACOTIAMIDE ............................................................................................................................ 124

Summary ......................................................................................................................................... 124

Originators ....................................................................................................................................... 124


Clinical Data: .................................................................................................................................... 124

11) ACTELION-1 ............................................................................................................................. 126

Summary ......................................................................................................................................... 126

Originators ....................................................................................................................................... 127


Clinical Data: .................................................................................................................................... 127

12) ACTIMMUNE ............................................................................................................................ 129

Summary ......................................................................................................................................... 129

Originators ....................................................................................................................................... 129



Clinical Data: .................................................................................................................................... 129

13) ACYCLOVIR ............................................................................................................................... 131

Summary ......................................................................................................................................... 131

Originators ....................................................................................................................................... 132


Clinical Data: .................................................................................................................................... 132

14) AD-923 ..................................................................................................................................... 134

Summary ......................................................................................................................................... 134

Originators ....................................................................................................................................... 134


Clinical Data: .................................................................................................................................... 134

15) ADENOVIRUS TYPES 4 AND 7 LIVE ORAL VACCINES ................................................................ 136

Summary ......................................................................................................................................... 136

Originators ....................................................................................................................................... 136


Clinical Data: .................................................................................................................................... 137

16) ADI-PEG-20 .............................................................................................................................. 139

Summary ......................................................................................................................................... 139

Originators ....................................................................................................................................... 139


Clinical Data: .................................................................................................................................... 139

17) ADLEA ...................................................................................................................................... 141

Summary ......................................................................................................................................... 141

Originators ....................................................................................................................................... 141


Clinical Data: .................................................................................................................................... 141

18) ADRENOCHROME MONOSEMICARBAZONE ............................................................................ 143

Summary ......................................................................................................................................... 144

Originators ....................................................................................................................................... 144


Clinical Data: .................................................................................................................................... 144

19) ADS-5101 ................................................................................................................................. 146


Summary ......................................................................................................................................... 146

Originators ....................................................................................................................................... 146


Clinical Data: .................................................................................................................................... 146

20) ADULT MYOGENIC STEM CELL THERAPY ................................................................................. 148

Summary ......................................................................................................................................... 149

Originators ....................................................................................................................................... 149


Clinical Data: .................................................................................................................................... 149

21) AERUGEN ................................................................................................................................. 151

Summary ......................................................................................................................................... 151

Originators ....................................................................................................................................... 151


Clinical Data: .................................................................................................................................... 151

22) AFAMELANOTIDE ..................................................................................................................... 153

Summary ......................................................................................................................................... 154

Originators ....................................................................................................................................... 154


Clinical Data: .................................................................................................................................... 154

23) AGOMELATINE ......................................................................................................................... 156

Summary ......................................................................................................................................... 156

Originators ....................................................................................................................................... 156


Clinical Data: .................................................................................................................................... 156

24) AIDSVAX ................................................................................................................................... 158

Summary ......................................................................................................................................... 159

Originators ....................................................................................................................................... 159


Clinical Data: .................................................................................................................................... 159

25) AK-120 ..................................................................................................................................... 161

Summary ......................................................................................................................................... 161

Originators ....................................................................................................................................... 161



Clinical Data: .................................................................................................................................... 161

26) ALBIGLUTIDE ............................................................................................................................ 163

Summary ......................................................................................................................................... 164

Originators ....................................................................................................................................... 164


Clinical Data: .................................................................................................................................... 164

27) ALENDRONATE (EFFERVESCENT) ............................................................................................. 166

Summary ......................................................................................................................................... 166

Originators ....................................................................................................................................... 166


Clinical Data: .................................................................................................................................... 166

28) ALFERMINOGENE TADENOVEC ............................................................................................... 168

Summary ......................................................................................................................................... 169

Originators ....................................................................................................................................... 169


Clinical Data: .................................................................................................................................... 169

29) ALISTA ...................................................................................................................................... 171

Summary ......................................................................................................................................... 171

Originators ....................................................................................................................................... 171


Clinical Data: .................................................................................................................................... 171

30) ALLOVECTIN-7.......................................................................................................................... 173

Summary ......................................................................................................................................... 174

Originators ....................................................................................................................................... 174


Clinical Data: .................................................................................................................................... 174

31) ALMOREXANT .......................................................................................................................... 176

Summary ......................................................................................................................................... 176

Originators ....................................................................................................................................... 176


Clinical Data: .................................................................................................................................... 176


32) ALPHA-1 ANTITRYPSIN (KAMADA) .......................................................................................... 178

Summary ......................................................................................................................................... 179

Originators ....................................................................................................................................... 179


Clinical Data: .................................................................................................................................... 179

33) ALPROSTADIL + PRAZOSIN ....................................................................................................... 181

Summary ......................................................................................................................................... 181

Originators ....................................................................................................................................... 181


Clinical Data: .................................................................................................................................... 181

34) ALS-02 ...................................................................................................................................... 183

Summary ......................................................................................................................................... 184

Originators ....................................................................................................................................... 184


Clinical Data: .................................................................................................................................... 184

35) ALTROPANE ............................................................................................................................. 186

Summary ......................................................................................................................................... 186

Originators ....................................................................................................................................... 186


Clinical Data: .................................................................................................................................... 186

36) ALVAC ...................................................................................................................................... 188

Summary ......................................................................................................................................... 189

Originators ....................................................................................................................................... 189


Clinical Data: .................................................................................................................................... 189

37) ALVOCIDIB ............................................................................................................................... 191

Summary ......................................................................................................................................... 191

Originators ....................................................................................................................................... 191


Clinical Data: .................................................................................................................................... 191

38) AMBISOME .............................................................................................................................. 193

Summary ......................................................................................................................................... 194


Originators ....................................................................................................................................... 194


Clinical Data: .................................................................................................................................... 194

39) AMBRISENTAN ......................................................................................................................... 196

Summary ......................................................................................................................................... 196

Originators ....................................................................................................................................... 196


Clinical Data: .................................................................................................................................... 196

40) AMEDIPLASE ............................................................................................................................ 198

Summary ......................................................................................................................................... 199

Originators ....................................................................................................................................... 199


Clinical Data: .................................................................................................................................... 199

41) AMINOCAPROIC ACID .............................................................................................................. 201

Summary ......................................................................................................................................... 201

Originators ....................................................................................................................................... 201


Clinical Data: .................................................................................................................................... 201

42) AMONAFIDE MALATE .............................................................................................................. 203

Summary ......................................................................................................................................... 204

Originators ....................................................................................................................................... 204


Clinical Data: .................................................................................................................................... 204

43) AMRUBICIN .............................................................................................................................. 206

Summary ......................................................................................................................................... 206

Originators ....................................................................................................................................... 206


Clinical Data: .................................................................................................................................... 206

44) AMT-011 .................................................................................................................................. 208

Summary ......................................................................................................................................... 209

Originators ....................................................................................................................................... 209



Clinical Data: .................................................................................................................................... 209

45) AN-072 ..................................................................................................................................... 211

Summary ......................................................................................................................................... 211

Originators ....................................................................................................................................... 211


Clinical Data: .................................................................................................................................... 211

46) ANDROGEN .............................................................................................................................. 213

Summary ......................................................................................................................................... 214

Originators ....................................................................................................................................... 214


Clinical Data: .................................................................................................................................... 214

47) ANX-510 ................................................................................................................................... 216

Summary ......................................................................................................................................... 216

Originators ....................................................................................................................................... 216


Clinical Data: .................................................................................................................................... 216

48) ANYARA ................................................................................................................................... 218

Summary ......................................................................................................................................... 219

Originators ....................................................................................................................................... 219


Clinical Data: .................................................................................................................................... 219

49) APADENOSON .......................................................................................................................... 221

Summary ......................................................................................................................................... 221

Originators ....................................................................................................................................... 221


Clinical Data: .................................................................................................................................... 221

50) APAZIQUONE ........................................................................................................................... 223

Summary ......................................................................................................................................... 224

Originators ....................................................................................................................................... 224


Clinical Data: .................................................................................................................................... 224

51) APIXABAN ................................................................................................................................ 226


Summary ......................................................................................................................................... 226

Originators ....................................................................................................................................... 226


Clinical Data: .................................................................................................................................... 226

52) APL-202 .................................................................................................................................... 228

Summary ......................................................................................................................................... 229

Originators ....................................................................................................................................... 229


Clinical Data: .................................................................................................................................... 229

53) APLIGRAF ................................................................................................................................. 231

Summary ......................................................................................................................................... 231

Originators ....................................................................................................................................... 231


Clinical Data: .................................................................................................................................... 231

54) ARENEGYR ............................................................................................................................... 233

Summary ......................................................................................................................................... 234

Originators ....................................................................................................................................... 234


Clinical Data: .................................................................................................................................... 234

55) ARGATROBAN .......................................................................................................................... 236

Summary ......................................................................................................................................... 236

Originators ....................................................................................................................................... 236


Clinical Data: .................................................................................................................................... 236

56) ARILVAX ................................................................................................................................... 238

Summary ......................................................................................................................................... 239

Originators ....................................................................................................................................... 239


Clinical Data: .................................................................................................................................... 239

57) AROFYLLINE ............................................................................................................................. 241

Summary ......................................................................................................................................... 241

Originators ....................................................................................................................................... 241



Clinical Data: .................................................................................................................................... 241

58) ART-123 ................................................................................................................................... 243

Summary ......................................................................................................................................... 244

Originators ....................................................................................................................................... 244


Clinical Data: .................................................................................................................................... 244

59) ARTEMETHER + LUMEFANTRINE ............................................................................................. 246

Summary ......................................................................................................................................... 246

Originators ....................................................................................................................................... 246


Clinical Data: .................................................................................................................................... 246

60) ARVERAPAMIL ......................................................................................................................... 248

Summary ......................................................................................................................................... 249

Originators ....................................................................................................................................... 249


Clinical Data: .................................................................................................................................... 249

61) ARZOXIFENE ............................................................................................................................. 251

Summary ......................................................................................................................................... 251

Originators ....................................................................................................................................... 251


Clinical Data: .................................................................................................................................... 251

62) ASA-404 ................................................................................................................................... 253

Summary ......................................................................................................................................... 254

Originators ....................................................................................................................................... 254


Clinical Data: .................................................................................................................................... 254

63) ASF-1057 .................................................................................................................................. 256

Summary ......................................................................................................................................... 256

Originators ....................................................................................................................................... 256


Clinical Data: .................................................................................................................................... 256


64) ASIMADOLINE .......................................................................................................................... 258

Summary ......................................................................................................................................... 259

Originators ....................................................................................................................................... 259


Clinical Data: .................................................................................................................................... 259

65) ASOPRISNIL .............................................................................................................................. 261

Summary ......................................................................................................................................... 261

Originators ....................................................................................................................................... 261


Clinical Data: .................................................................................................................................... 261

66) AST-726 .................................................................................................................................... 263

Summary ......................................................................................................................................... 264

Originators ....................................................................................................................................... 264


Clinical Data: .................................................................................................................................... 264

67) ATALUREN ............................................................................................................................... 266

Summary ......................................................................................................................................... 266

Originators ....................................................................................................................................... 266


Clinical Data: .................................................................................................................................... 267

68) ATAMESTANE .......................................................................................................................... 269

Summary ......................................................................................................................................... 269

Originators ....................................................................................................................................... 269


Clinical Data: .................................................................................................................................... 269

69) ATI-BC-1 ................................................................................................................................... 271

Summary ......................................................................................................................................... 271

Originators ....................................................................................................................................... 271


Clinical Data: .................................................................................................................................... 272

70) AV-45 ....................................................................................................................................... 274

Summary ......................................................................................................................................... 274


Originators ....................................................................................................................................... 274


Clinical Data: .................................................................................................................................... 274

71) AVANAFIL ................................................................................................................................. 276

Summary ......................................................................................................................................... 276

Originators ....................................................................................................................................... 277


Clinical Data: .................................................................................................................................... 277

72) AVE-5026 ................................................................................................................................. 279

Summary ......................................................................................................................................... 279

Originators ....................................................................................................................................... 279


Clinical Data: .................................................................................................................................... 279

73) AVE-8062 ................................................................................................................................. 281

Summary ......................................................................................................................................... 281

Originators ....................................................................................................................................... 282


Clinical Data: .................................................................................................................................... 282

74) AVIAN INFLUENZA VACCINE .................................................................................................... 284

Summary ......................................................................................................................................... 284

Originators ....................................................................................................................................... 284


Clinical Data: .................................................................................................................................... 284

75) AVIPTADIL ................................................................................................................................ 286

Summary ......................................................................................................................................... 287

Originators ....................................................................................................................................... 287


Clinical Data: .................................................................................................................................... 287

76) AVIPTADIL + PHENTOLAMINE MESYLATE ................................................................................ 289

Summary ......................................................................................................................................... 289

Originators ....................................................................................................................................... 289



Clinical Data: .................................................................................................................................... 289

77) AXITINIB ................................................................................................................................... 291

Summary ......................................................................................................................................... 292

Originators ....................................................................................................................................... 292


Clinical Data: .................................................................................................................................... 292

78) AZIMILIDE ................................................................................................................................ 294

Summary ......................................................................................................................................... 294

Originators ....................................................................................................................................... 294


Clinical Data: .................................................................................................................................... 294

81) AZITHROMYCIN + ANTI-INFLAMMATORY STEROID ................................................................. 297

Summary ......................................................................................................................................... 297

Originators ....................................................................................................................................... 297


Clinical Data: .................................................................................................................................... 297

82) BACLOFEN ER ........................................................................................................................... 299

Summary ......................................................................................................................................... 299

Originators ....................................................................................................................................... 300


Clinical Data: .................................................................................................................................... 300

83) BALAGLITAZONE ...................................................................................................................... 302

Summary ......................................................................................................................................... 302

Originators ....................................................................................................................................... 302


Clinical Data: .................................................................................................................................... 302

84) BAPINEUZUMAB ...................................................................................................................... 304

Summary ......................................................................................................................................... 304

Originators ....................................................................................................................................... 305


Clinical Data: .................................................................................................................................... 305

85) BAZEDOXIFENE + CONJUGATED ESTROGENS .......................................................................... 307


Summary ......................................................................................................................................... 307

Originators ....................................................................................................................................... 307


Clinical Data: .................................................................................................................................... 307

86) BCI-540 .................................................................................................................................... 309

Summary ......................................................................................................................................... 310

Originators ....................................................................................................................................... 310


Clinical Data: .................................................................................................................................... 310

87) BECLOMETHASONE DIPROPIONATE ........................................................................................ 312

Summary ......................................................................................................................................... 312

Originators ....................................................................................................................................... 312


Clinical Data: .................................................................................................................................... 312

88) BELAGENPUMATUCEL-L .......................................................................................................... 314

Summary ......................................................................................................................................... 315

Originators ....................................................................................................................................... 315


Clinical Data: .................................................................................................................................... 315

89) BENEFIN ................................................................................................................................... 317

Summary ......................................................................................................................................... 317

Originators ....................................................................................................................................... 317


Clinical Data: .................................................................................................................................... 318

90) BEPOTASTINE BESILATE ........................................................................................................... 320

Summary ......................................................................................................................................... 320

Originators ....................................................................................................................................... 320


Clinical Data: .................................................................................................................................... 320

91) BEVASIRANIB SODIUM ............................................................................................................ 322

Summary ......................................................................................................................................... 322

Originators ....................................................................................................................................... 322



Clinical Data: .................................................................................................................................... 323

92) BG-9928 ................................................................................................................................... 325

Summary ......................................................................................................................................... 325

Originators ....................................................................................................................................... 325


Clinical Data: .................................................................................................................................... 325

93) BIBW-2992 ............................................................................................................................... 327

Summary ......................................................................................................................................... 327

Originators ....................................................................................................................................... 328


Clinical Data: .................................................................................................................................... 328

94) BICIFADINE .............................................................................................................................. 330

Summary ......................................................................................................................................... 330

Originators ....................................................................................................................................... 330


Clinical Data: .................................................................................................................................... 330

95) BILASTINE ................................................................................................................................ 332

Summary ......................................................................................................................................... 332

Originators ....................................................................................................................................... 333


Clinical Data: .................................................................................................................................... 333

96) BILAYERED CELLULAR MATRIX................................................................................................. 335

Summary ......................................................................................................................................... 335

Originators ....................................................................................................................................... 335


Clinical Data: .................................................................................................................................... 335

97) BINODENOSON ........................................................................................................................ 337

Summary ......................................................................................................................................... 338

Originators ....................................................................................................................................... 338


Clinical Data: .................................................................................................................................... 338


98) BIOVAXID ................................................................................................................................. 340

Summary ......................................................................................................................................... 340

Originators ....................................................................................................................................... 340


Clinical Data: .................................................................................................................................... 340

99) BLEOMYCIN SULFATE .............................................................................................................. 342

Summary ......................................................................................................................................... 343

Originators ....................................................................................................................................... 343


Clinical Data: .................................................................................................................................... 343

100) BLONANSERIN ......................................................................................................................... 345

Summary ......................................................................................................................................... 345

Originators ....................................................................................................................................... 345


Clinical Data: .................................................................................................................................... 346

101) BLP-25 LIPOSOME VACCINE .................................................................................................... 348

Summary ......................................................................................................................................... 348

Originators ....................................................................................................................................... 348


Clinical Data: .................................................................................................................................... 348

102) BNP-1350 ................................................................................................................................. 350

Summary ......................................................................................................................................... 350

Originators ....................................................................................................................................... 350


Clinical Data: .................................................................................................................................... 351

103) BNP-7787 ................................................................................................................................. 353

Summary ......................................................................................................................................... 353

Originators ....................................................................................................................................... 353


Clinical Data: .................................................................................................................................... 353

104) BOTULINUM TOXIN TYPE A ..................................................................................................... 355

Summary ......................................................................................................................................... 355


Originators ....................................................................................................................................... 356


Clinical Data: .................................................................................................................................... 356

105) BRENTUXIMAB VEDOTIN ......................................................................................................... 358

Summary ......................................................................................................................................... 358

Originators ....................................................................................................................................... 358


Clinical Data: .................................................................................................................................... 358

106) BRIVARACETAM ....................................................................................................................... 360

Summary ......................................................................................................................................... 360

Originators ....................................................................................................................................... 361


Clinical Data: .................................................................................................................................... 361

107) BSI-201 ..................................................................................................................................... 363

Summary ......................................................................................................................................... 363

Originators ....................................................................................................................................... 363


Clinical Data: .................................................................................................................................... 363

108) BUDESONIDE ........................................................................................................................... 365

Summary ......................................................................................................................................... 366

Originators ....................................................................................................................................... 366


Clinical Data: .................................................................................................................................... 366

109) BUDESONIDE (INHALED NEBULIZED, ASTHMA) ...................................................................... 368

Summary ......................................................................................................................................... 368

Originators ....................................................................................................................................... 368


Clinical Data: .................................................................................................................................... 368

110) BUPIVACAINE ........................................................................................................................... 370

Summary ......................................................................................................................................... 371

Originators ....................................................................................................................................... 371



Clinical Data: .................................................................................................................................... 371

111) BUPRENORPHINE ..................................................................................................................... 373

Summary ......................................................................................................................................... 373

Originators ....................................................................................................................................... 373


Clinical Data: .................................................................................................................................... 374

112) C-9280 ..................................................................................................................................... 376

Summary ......................................................................................................................................... 376

Originators ....................................................................................................................................... 376


Clinical Data: .................................................................................................................................... 376

113) C1-INH ..................................................................................................................................... 378

Summary ......................................................................................................................................... 378

Originators ....................................................................................................................................... 378


Clinical Data: .................................................................................................................................... 379

114) CA9-SCAN ................................................................................................................................ 381

Summary ......................................................................................................................................... 381

Originators ....................................................................................................................................... 381


Clinical Data: .................................................................................................................................... 381

115) CAIV-T ...................................................................................................................................... 383

Summary ......................................................................................................................................... 383

Originators ....................................................................................................................................... 384


Clinical Data: .................................................................................................................................... 384

116) CANFOSFAMIDE HCL ............................................................................................................... 386

Summary ......................................................................................................................................... 386

Originators ....................................................................................................................................... 386


Clinical Data: .................................................................................................................................... 386

117) CANGRELOR ............................................................................................................................. 388


Summary ......................................................................................................................................... 388

Originators ....................................................................................................................................... 389


Clinical Data: .................................................................................................................................... 389

118) CARBAMAZEPINE ..................................................................................................................... 391

Summary ......................................................................................................................................... 391

Originators ....................................................................................................................................... 391


Clinical Data: .................................................................................................................................... 391

119) CARBIDOPA + LEVODOPA CR ................................................................................................... 393

Summary ......................................................................................................................................... 394

Originators ....................................................................................................................................... 394


Clinical Data: .................................................................................................................................... 394

120) CARFILZOMIB ........................................................................................................................... 396

Summary ......................................................................................................................................... 396

Originators ....................................................................................................................................... 396


Clinical Data: .................................................................................................................................... 396

121) CARUMONAM ......................................................................................................................... 398

Summary ......................................................................................................................................... 399

Originators ....................................................................................................................................... 399


Clinical Data: .................................................................................................................................... 399

122) CBP-1011 ................................................................................................................................. 401

Summary ......................................................................................................................................... 401

Originators ....................................................................................................................................... 401


Clinical Data: .................................................................................................................................... 402

123) CCR9 ANTAGONIST .................................................................................................................. 404

Summary ......................................................................................................................................... 404

Originators ....................................................................................................................................... 404



Clinical Data: .................................................................................................................................... 404

124) CEE-04-410 .............................................................................................................................. 406

Summary ......................................................................................................................................... 406

Originators ....................................................................................................................................... 406


Clinical Data: .................................................................................................................................... 407

125) CEFTAROLINE ACETATE ........................................................................................................... 409

Summary ......................................................................................................................................... 409

Originators ....................................................................................................................................... 409


Clinical Data: .................................................................................................................................... 409

126) CEFTIZOXIME ALAPIVOXIL ....................................................................................................... 411

Summary ......................................................................................................................................... 411

Originators ....................................................................................................................................... 412


Clinical Data: .................................................................................................................................... 412

127) CELACADE TECHNOLOGY ......................................................................................................... 414

Summary ......................................................................................................................................... 414

Originators ....................................................................................................................................... 414


Clinical Data: .................................................................................................................................... 414

128) CEM-102 .................................................................................................................................. 416

Summary ......................................................................................................................................... 416

Originators ....................................................................................................................................... 417


Clinical Data: .................................................................................................................................... 417

129) CETHROMYCIN ......................................................................................................................... 419

Summary ......................................................................................................................................... 419

Originators ....................................................................................................................................... 419


Clinical Data: .................................................................................................................................... 419


130) CETILISTAT ............................................................................................................................... 421

Summary ......................................................................................................................................... 422

Originators ....................................................................................................................................... 422


Clinical Data: .................................................................................................................................... 422

131) CETRORELIX ............................................................................................................................. 424

Summary ......................................................................................................................................... 424

Originators ....................................................................................................................................... 424


Clinical Data: .................................................................................................................................... 424

132) CF-101 ...................................................................................................................................... 426

Summary ......................................................................................................................................... 427

Originators ....................................................................................................................................... 427


Clinical Data: .................................................................................................................................... 427

133) CHIMERIVAX-JE ........................................................................................................................ 429

Summary ......................................................................................................................................... 429

Originators ....................................................................................................................................... 429


Clinical Data: .................................................................................................................................... 430

134) CHLORPROGUANIL + DAPSONE + ARTESUNATE ..................................................................... 432

Summary ......................................................................................................................................... 432

Originators ....................................................................................................................................... 432


Clinical Data: .................................................................................................................................... 432

135) CICLOPIROX ............................................................................................................................. 434

Summary ......................................................................................................................................... 434

Originators ....................................................................................................................................... 434


Clinical Data: .................................................................................................................................... 435

136) CINTREDEKIN BESUDOTOX ...................................................................................................... 437

Summary ......................................................................................................................................... 437


Originators ....................................................................................................................................... 437


Clinical Data: .................................................................................................................................... 437

137) CISPLATIN ................................................................................................................................ 439

Summary ......................................................................................................................................... 439

Originators ....................................................................................................................................... 440


Clinical Data: .................................................................................................................................... 440

138) CITICOLINE ............................................................................................................................... 442

Summary ......................................................................................................................................... 442

Originators ....................................................................................................................................... 442


Clinical Data: .................................................................................................................................... 442

139) CLADRIBINE ............................................................................................................................. 444

Summary ......................................................................................................................................... 445

Originators ....................................................................................................................................... 445


Clinical Data: .................................................................................................................................... 445

140) CLAZOSENTAN ......................................................................................................................... 447

Summary ......................................................................................................................................... 447

Originators ....................................................................................................................................... 447


Clinical Data: .................................................................................................................................... 448

141) CLEVUDINE .............................................................................................................................. 450

Summary ......................................................................................................................................... 450

Originators ....................................................................................................................................... 450


Clinical Data: .................................................................................................................................... 450

142) CLINDAMYCIN .......................................................................................................................... 452

Summary ......................................................................................................................................... 452

Originators ....................................................................................................................................... 452



Clinical Data: .................................................................................................................................... 453

143) CLINDAMYCIN PHOSPHATE/TRETINOIN GEL ........................................................................... 455

Summary ......................................................................................................................................... 455

Originators ....................................................................................................................................... 455


Clinical Data: .................................................................................................................................... 455

144) CLOBAZAM .............................................................................................................................. 457

Summary ......................................................................................................................................... 457

Originators ....................................................................................................................................... 458


Clinical Data: .................................................................................................................................... 458

145) CLONIDINE HYDROCHLORIDE ER ............................................................................................. 460

Summary ......................................................................................................................................... 460

Originators ....................................................................................................................................... 460


Clinical Data: .................................................................................................................................... 460

146) CLOPIDOGREL .......................................................................................................................... 462

Summary ......................................................................................................................................... 462

Originators ....................................................................................................................................... 463


Clinical Data: .................................................................................................................................... 463

147) CM-AT ...................................................................................................................................... 465

Summary ......................................................................................................................................... 465

Originators ....................................................................................................................................... 465


Clinical Data: .................................................................................................................................... 465

148) CODEINE PHOSPHATE .............................................................................................................. 467

Summary ......................................................................................................................................... 468

Originators ....................................................................................................................................... 468


Clinical Data: .................................................................................................................................... 468

149) COLLARX GENTAMICIN SURGICAL IMPLANT ........................................................................... 470


Summary ......................................................................................................................................... 470

Originators ....................................................................................................................................... 470


Clinical Data: .................................................................................................................................... 470

150) COMBRETASTATIN-A4 PHOSPHATE ........................................................................................ 472

Summary ......................................................................................................................................... 473

Originators ....................................................................................................................................... 473


Clinical Data: .................................................................................................................................... 473

151) CP-690550 ............................................................................................................................... 475

Summary ......................................................................................................................................... 475

Originators ....................................................................................................................................... 475


Clinical Data: .................................................................................................................................... 476

152) CPC-211 ................................................................................................................................... 478

Summary ......................................................................................................................................... 478

Originators ....................................................................................................................................... 478


Clinical Data: .................................................................................................................................... 478

153) CROFELEMER ........................................................................................................................... 480

Summary ......................................................................................................................................... 480

Originators ....................................................................................................................................... 480


Clinical Data: .................................................................................................................................... 481

154) CTP-37...................................................................................................................................... 483

Summary ......................................................................................................................................... 483

Originators ....................................................................................................................................... 483


Clinical Data: .................................................................................................................................... 483

155) CV-247 ..................................................................................................................................... 485

Summary ......................................................................................................................................... 485

Originators ....................................................................................................................................... 486



Clinical Data: .................................................................................................................................... 486

156) CX-401 ..................................................................................................................................... 488

Summary ......................................................................................................................................... 488

Originators ....................................................................................................................................... 488


Clinical Data: .................................................................................................................................... 488

157) CYANOCOBALAMIN (ALLERGIC RHINITIS)................................................................................ 490

Summary ......................................................................................................................................... 490

Originators ....................................................................................................................................... 491


Clinical Data: .................................................................................................................................... 491

158) CYCLOSPORINE ........................................................................................................................ 493

Summary ......................................................................................................................................... 493

Originators ....................................................................................................................................... 493


Clinical Data: .................................................................................................................................... 493

159) CYCLOSPORINE A (DRY EYE) .................................................................................................... 495

Summary ......................................................................................................................................... 496

Originators ....................................................................................................................................... 496


Clinical Data: .................................................................................................................................... 496

160) CYCLOSPORINE A (VERNAL KERATOCONJUNCTIVITIS) ............................................................ 498

Summary ......................................................................................................................................... 498

Originators ....................................................................................................................................... 498


Clinical Data: .................................................................................................................................... 498

161) CYPROTERONE ......................................................................................................................... 500

Summary ......................................................................................................................................... 501

Originators ....................................................................................................................................... 501


Clinical Data: .................................................................................................................................... 501


162) CYTOMEGALOVIRUS CELL THERAPY ........................................................................................ 503

Summary ......................................................................................................................................... 503

Originators ....................................................................................................................................... 503


Clinical Data: .................................................................................................................................... 504

163) DACLIZUMAB ........................................................................................................................... 506

Summary ......................................................................................................................................... 506

Originators ....................................................................................................................................... 506


Clinical Data: .................................................................................................................................... 506

164) DAPAGLIFLOZIN ....................................................................................................................... 508

Summary ......................................................................................................................................... 508

Originators ....................................................................................................................................... 508


Clinical Data: .................................................................................................................................... 509

165) DAPOXETINE ............................................................................................................................ 511

Summary ......................................................................................................................................... 511

Originators ....................................................................................................................................... 511


Clinical Data: .................................................................................................................................... 511

166) DARAPLADIB ............................................................................................................................ 513

Summary ......................................................................................................................................... 513

Originators ....................................................................................................................................... 514


Clinical Data: .................................................................................................................................... 514

167) DARUSENTAN .......................................................................................................................... 516

Summary ......................................................................................................................................... 516

Originators ....................................................................................................................................... 516


Clinical Data: .................................................................................................................................... 516

168) DCVAX-PROSTATE .................................................................................................................... 518

Summary ......................................................................................................................................... 518


Originators ....................................................................................................................................... 519


Clinical Data: .................................................................................................................................... 519

169) DEFIBROTIDE ........................................................................................................................... 521

Summary ......................................................................................................................................... 521

Originators ....................................................................................................................................... 521


Clinical Data: .................................................................................................................................... 521

170) DEGLUDEC ............................................................................................................................... 523

Summary ......................................................................................................................................... 524

Originators ....................................................................................................................................... 524


Clinical Data: .................................................................................................................................... 524

171) DEHYDRODIDEMNIN B ............................................................................................................ 526

Summary ......................................................................................................................................... 527

Originators ....................................................................................................................................... 527


Clinical Data: .................................................................................................................................... 527

172) DENOSUMAB ........................................................................................................................... 529

Summary ......................................................................................................................................... 529

Originators ....................................................................................................................................... 529


Clinical Data: .................................................................................................................................... 530

173) DEPOBUPIVACAINE.................................................................................................................. 532

Summary ......................................................................................................................................... 532

Originators ....................................................................................................................................... 532


Clinical Data: .................................................................................................................................... 532

174) DESLORATADINE ...................................................................................................................... 534

Summary ......................................................................................................................................... 534

Originators ....................................................................................................................................... 534



Clinical Data: .................................................................................................................................... 535

175) DESLORELIN + ESTRADIOL + TESTOSTERONE .......................................................................... 537

Summary ......................................................................................................................................... 537

Originators ....................................................................................................................................... 537


Clinical Data: .................................................................................................................................... 537

176) DESMOTEPLASE ....................................................................................................................... 539

Summary ......................................................................................................................................... 539

Originators ....................................................................................................................................... 540


Clinical Data: .................................................................................................................................... 540

177) DESONIDE ................................................................................................................................ 542

Summary ......................................................................................................................................... 542

Originators ....................................................................................................................................... 542


Clinical Data: .................................................................................................................................... 542

178) DEXAMETHASONE ................................................................................................................... 544

Summary ......................................................................................................................................... 544

Originators ....................................................................................................................................... 545


Clinical Data: .................................................................................................................................... 545

179) DEXLOXIGLUMIDE.................................................................................................................... 547

Summary ......................................................................................................................................... 547

Originators ....................................................................................................................................... 547


Clinical Data: .................................................................................................................................... 547

180) DEXTROMETHORPHAN + QUINIDINE ...................................................................................... 549

Summary ......................................................................................................................................... 550

Originators ....................................................................................................................................... 550


Clinical Data: .................................................................................................................................... 550

181) DG-031 ..................................................................................................................................... 552


Summary ......................................................................................................................................... 552

Originators ....................................................................................................................................... 552


Clinical Data: .................................................................................................................................... 552

182) DIAMYD DIABETES VACCINE .................................................................................................... 554

Summary ......................................................................................................................................... 555

Originators ....................................................................................................................................... 555


Clinical Data: .................................................................................................................................... 555

183) DIAPEP-277 .............................................................................................................................. 557

Summary ......................................................................................................................................... 557

Originators ....................................................................................................................................... 557


Clinical Data: .................................................................................................................................... 558

184) DICLOFENAC SODIUM ............................................................................................................. 560

Summary ......................................................................................................................................... 560

Originators ....................................................................................................................................... 560


Clinical Data: .................................................................................................................................... 560

185) DIFLUPREDNATE ...................................................................................................................... 562

Summary ......................................................................................................................................... 562

Originators ....................................................................................................................................... 562


Clinical Data: .................................................................................................................................... 563

186) DIHYDROARTEMISININ + PIPERAQUINE .................................................................................. 565

Summary ......................................................................................................................................... 565

Originators ....................................................................................................................................... 565


Clinical Data: .................................................................................................................................... 565

187) DILTIAZEM HYDROCHLORIDE .................................................................................................. 567

Summary ......................................................................................................................................... 567

Originators ....................................................................................................................................... 568



Clinical Data: .................................................................................................................................... 568

188) DIMEBON ................................................................................................................................. 570

Summary ......................................................................................................................................... 570

Originators ....................................................................................................................................... 570


Clinical Data: .................................................................................................................................... 570

189) DIMETHYL FUMARATE ............................................................................................................. 572

Summary ......................................................................................................................................... 572

Originators ....................................................................................................................................... 573


Clinical Data: .................................................................................................................................... 573

190) DIQUAFOSOL TETRASODIUM .................................................................................................. 575

Summary ......................................................................................................................................... 575

Originators ....................................................................................................................................... 575


Clinical Data: .................................................................................................................................... 575

191) DIRUCOTIDE ............................................................................................................................. 577

Summary ......................................................................................................................................... 578

Originators ....................................................................................................................................... 578


Clinical Data: .................................................................................................................................... 578

192) DN-101 ..................................................................................................................................... 580

Summary ......................................................................................................................................... 580

Originators ....................................................................................................................................... 580


Clinical Data: .................................................................................................................................... 580

193) DOXORUBICIN (HEAT-SENSITIVE LIPOSOMAL ......................................................................... 582

Summary ......................................................................................................................................... 583

Originators ....................................................................................................................................... 583


Clinical Data: .................................................................................................................................... 583


194) DP-B99 ..................................................................................................................................... 585

Summary ......................................................................................................................................... 585

Originators ....................................................................................................................................... 585


Clinical Data: .................................................................................................................................... 586

195) DROXIDOPA ............................................................................................................................. 588

Summary ......................................................................................................................................... 588

Originators ....................................................................................................................................... 588


Clinical Data: .................................................................................................................................... 588

196) DTP-HBV-POLIO-HIB VACCINE ................................................................................................. 590

Summary ......................................................................................................................................... 590

Originators ....................................................................................................................................... 590


Clinical Data: .................................................................................................................................... 591

197) DTPW-HBV VACCINE................................................................................................................ 593

Summary ......................................................................................................................................... 593

Originators ....................................................................................................................................... 593


Clinical Data: .................................................................................................................................... 593

198) DUTOGLIPTIN ........................................................................................................................... 595

Summary ......................................................................................................................................... 595

Originators ....................................................................................................................................... 596


Clinical Data: .................................................................................................................................... 596

199) DWP-412 .................................................................................................................................. 598

Summary ......................................................................................................................................... 598

Originators ....................................................................................................................................... 598


Clinical Data: .................................................................................................................................... 598

200) DWP-413 .................................................................................................................................. 600

Summary ......................................................................................................................................... 600


Originators ....................................................................................................................................... 601


Clinical Data: .................................................................................................................................... 601

201) ECADOTRIL ............................................................................................................................... 603

Summary ......................................................................................................................................... 603

Originators ....................................................................................................................................... 603


Clinical Data: .................................................................................................................................... 603

202) ECALLANTIDE ........................................................................................................................... 605

Summary ......................................................................................................................................... 606

Originators ....................................................................................................................................... 606


Clinical Data: .................................................................................................................................... 606

203) EDOXABAN TOSYLATE ............................................................................................................. 608

Summary ......................................................................................................................................... 608

Originators ....................................................................................................................................... 608


Clinical Data: .................................................................................................................................... 608

204) EFLETIRIZINE ............................................................................................................................ 610

Summary ......................................................................................................................................... 611

Originators ....................................................................................................................................... 611


Clinical Data: .................................................................................................................................... 611

205) EG-006 ..................................................................................................................................... 613

Summary ......................................................................................................................................... 613

Originators ....................................................................................................................................... 613


Clinical Data: .................................................................................................................................... 614

206) EGB-761 ................................................................................................................................... 616

Summary ......................................................................................................................................... 616

Originators ....................................................................................................................................... 616



Clinical Data: .................................................................................................................................... 616

207) EGP-437 ................................................................................................................................... 618

Summary ......................................................................................................................................... 618

Originators ....................................................................................................................................... 618


Clinical Data: .................................................................................................................................... 619

208) EHT-201 ................................................................................................................................... 621

Summary ......................................................................................................................................... 621

Originators ....................................................................................................................................... 621


Clinical Data: .................................................................................................................................... 621

209) ELDECALCITOL ......................................................................................................................... 623

Summary ......................................................................................................................................... 623

Originators ....................................................................................................................................... 624


Clinical Data: .................................................................................................................................... 624

210) ELESCLOMOL ........................................................................................................................... 626

Summary ......................................................................................................................................... 626

Originators ....................................................................................................................................... 626


Clinical Data: .................................................................................................................................... 626

211) ELIGLUSTAT TARTRATE ............................................................................................................ 628

Summary ......................................................................................................................................... 628

Originators ....................................................................................................................................... 629


Clinical Data: .................................................................................................................................... 629

212) ELVITEGRAVIR .......................................................................................................................... 631

Summary ......................................................................................................................................... 631

Originators ....................................................................................................................................... 631


Clinical Data: .................................................................................................................................... 631

213) ELVITEGRAVIR + COBICISTAT + TRUVADA ............................................................................... 633


Summary ......................................................................................................................................... 634

Originators ....................................................................................................................................... 634


Clinical Data: .................................................................................................................................... 634

214) EN-3231 ................................................................................................................................... 636

Summary ......................................................................................................................................... 636

Originators ....................................................................................................................................... 636


Clinical Data: .................................................................................................................................... 636

215) ENCLOMIPHENE....................................................................................................................... 638

Summary ......................................................................................................................................... 639

Originators ....................................................................................................................................... 639


Clinical Data: .................................................................................................................................... 639

216) ENDOMETRION ........................................................................................................................ 641

Summary ......................................................................................................................................... 641

Originators ....................................................................................................................................... 641


Clinical Data: .................................................................................................................................... 642

217) EPIRETINAL BRACHYTHERAPY ................................................................................................. 644

Summary ......................................................................................................................................... 644

Originators ....................................................................................................................................... 644


Clinical Data: .................................................................................................................................... 644

218) EPLERENONE ........................................................................................................................... 646

Summary ......................................................................................................................................... 646

Originators ....................................................................................................................................... 646


Clinical Data: .................................................................................................................................... 647

219) EPOETIN OMEGA ..................................................................................................................... 649

Summary ......................................................................................................................................... 649

Originators ....................................................................................................................................... 649



Clinical Data: .................................................................................................................................... 649

220) EPRATUZUMAB ........................................................................................................................ 651

Summary ......................................................................................................................................... 651

Originators ....................................................................................................................................... 652


Clinical Data: .................................................................................................................................... 652

221) EPRODISATE ............................................................................................................................. 654

Summary ......................................................................................................................................... 654

Originators ....................................................................................................................................... 654


Clinical Data: .................................................................................................................................... 654

222) EPTOTERMIN ALFA .................................................................................................................. 656

Summary ......................................................................................................................................... 656

Originators ....................................................................................................................................... 657


Clinical Data: .................................................................................................................................... 657

223) ERITORAN TETRASODIUM ....................................................................................................... 659

Summary ......................................................................................................................................... 659

Originators ....................................................................................................................................... 659


Clinical Data: .................................................................................................................................... 659

224) ESLICARBAZEPINE ACETATE ..................................................................................................... 661

Summary ......................................................................................................................................... 662

Originators ....................................................................................................................................... 662


Clinical Data: .................................................................................................................................... 662

225) ESOXYBUTYNIN ........................................................................................................................ 664

Summary ......................................................................................................................................... 664

Originators ....................................................................................................................................... 664


Clinical Data: .................................................................................................................................... 664


226) ESREBOXETINE ......................................................................................................................... 666

Summary ......................................................................................................................................... 667

Originators ....................................................................................................................................... 667


Clinical Data: .................................................................................................................................... 667

227) ESTRADIOL + LEVONORGESTREL TRANSDERMAL .................................................................... 669

Summary ......................................................................................................................................... 669

Originators ....................................................................................................................................... 669


Clinical Data: .................................................................................................................................... 670

228) ESTROGEN/PROGESTOGEN COMBINATION GEL ..................................................................... 672

Summary ......................................................................................................................................... 672

Originators ....................................................................................................................................... 672


Clinical Data: .................................................................................................................................... 672

229) ETHEOPHAZINE ........................................................................................................................ 674

Summary ......................................................................................................................................... 674

Originators ....................................................................................................................................... 674


Clinical Data: .................................................................................................................................... 675

230) EXTENDED RELEASE NIACIN + LAROPIPRANT + ....................................................................... 677

Summary ......................................................................................................................................... 677

Originators ....................................................................................................................................... 677


Clinical Data: .................................................................................................................................... 677

231) FASORACETAM ........................................................................................................................ 679

Summary ......................................................................................................................................... 679

Originators ....................................................................................................................................... 680


Clinical Data: .................................................................................................................................... 680

232) FENANTYL ................................................................................................................................ 682

Summary ......................................................................................................................................... 682


Originators ....................................................................................................................................... 682


Clinical Data: .................................................................................................................................... 682

233) FENTANYL SUBLINGUAL SPRAY ............................................................................................... 684

Summary ......................................................................................................................................... 684

Originators ....................................................................................................................................... 685


Clinical Data: .................................................................................................................................... 685

234) FIGITUMUMAB ........................................................................................................................ 687

Summary ......................................................................................................................................... 687

Originators ....................................................................................................................................... 687


Clinical Data: .................................................................................................................................... 687

235) FLIBANSERIN ............................................................................................................................ 689

Summary ......................................................................................................................................... 690

Originators ....................................................................................................................................... 690


Clinical Data: .................................................................................................................................... 690

236) FLUOXETINE (AUTISM) ............................................................................................................ 692

Summary ......................................................................................................................................... 692

Originators ....................................................................................................................................... 692


Clinical Data: .................................................................................................................................... 692

237) FLUTICASONE + AZELASTINE ................................................................................................... 694

Summary ......................................................................................................................................... 695

Originators ....................................................................................................................................... 695


Clinical Data: .................................................................................................................................... 695

238) FLUTICASONE + FORMOTEROL ................................................................................................ 697

Summary ......................................................................................................................................... 697

Originators ....................................................................................................................................... 697



Clinical Data: .................................................................................................................................... 698

239) FOSPHENYTOIN SODIUM ......................................................................................................... 700

Summary ......................................................................................................................................... 700

Originators ....................................................................................................................................... 700


Clinical Data: .................................................................................................................................... 700

240) GABAPENTIN............................................................................................................................ 702

Summary ......................................................................................................................................... 702

Originators ....................................................................................................................................... 702


Clinical Data: .................................................................................................................................... 703

241) GABEXATE MESILATE ............................................................................................................... 705

Summary ......................................................................................................................................... 705

Originators ....................................................................................................................................... 705


Clinical Data: .................................................................................................................................... 705

242) GADOMELITOL ......................................................................................................................... 707

Summary ......................................................................................................................................... 707

Originators ....................................................................................................................................... 708


Clinical Data: .................................................................................................................................... 708

243) GALACTOMANNAN-C .............................................................................................................. 710

Summary ......................................................................................................................................... 710

Originators ....................................................................................................................................... 710


Clinical Data: .................................................................................................................................... 710

244) GALIXIMAB .............................................................................................................................. 712

Summary ......................................................................................................................................... 712

Originators ....................................................................................................................................... 713


Clinical Data: .................................................................................................................................... 713

245) GARENOXACIN ......................................................................................................................... 715


Summary ......................................................................................................................................... 715

Originators ....................................................................................................................................... 715


Clinical Data: .................................................................................................................................... 715

246) GASTRIMMUNE ....................................................................................................................... 717

Summary ......................................................................................................................................... 718

Originators ....................................................................................................................................... 718


Clinical Data: .................................................................................................................................... 718

247) GENE THERAPY (LYMPHOMA) ................................................................................................. 720

Summary ......................................................................................................................................... 720

Originators ....................................................................................................................................... 720


Clinical Data: .................................................................................................................................... 720

248) GEPIRONE ................................................................................................................................ 722

Summary ......................................................................................................................................... 723

Originators ....................................................................................................................................... 723


Clinical Data: .................................................................................................................................... 723

249) GINGER EXTRACT ..................................................................................................................... 725

Summary ......................................................................................................................................... 725

Originators ....................................................................................................................................... 725


Clinical Data: .................................................................................................................................... 726

250) GLUFOSFAMIDE ....................................................................................................................... 728

Summary ......................................................................................................................................... 728

Originators ....................................................................................................................................... 728


Clinical Data: .................................................................................................................................... 728

251) GLYCOPYRROLATE ................................................................................................................... 730

Summary ......................................................................................................................................... 730

Originators ....................................................................................................................................... 730



Clinical Data: .................................................................................................................................... 731

252) GLYMINOX ............................................................................................................................... 733

Summary ......................................................................................................................................... 733

Originators ....................................................................................................................................... 733


Clinical Data: .................................................................................................................................... 733

253) GLYPROMATE .......................................................................................................................... 735

Summary ......................................................................................................................................... 735

Originators ....................................................................................................................................... 736


Clinical Data: .................................................................................................................................... 736

254) GMK ......................................................................................................................................... 738

Summary ......................................................................................................................................... 738

Originators ....................................................................................................................................... 738


Clinical Data: .................................................................................................................................... 738

255) GRANISETRON HYDROCHLORIDE ............................................................................................ 740

Summary ......................................................................................................................................... 740

Originators ....................................................................................................................................... 741


Clinical Data: .................................................................................................................................... 741

256) GRANISETRON TRANSDERMAL DELIVERY SYSTEM ................................................................. 743

Summary ......................................................................................................................................... 743

Originators ....................................................................................................................................... 743


Clinical Data: .................................................................................................................................... 743

257) GRASPA .................................................................................................................................... 745

Summary ......................................................................................................................................... 746

Originators ....................................................................................................................................... 746


Clinical Data: .................................................................................................................................... 746


258) GRASS POLLEN ALLERGY DESENSITIZATION TABLET ............................................................... 748

Summary ......................................................................................................................................... 748

Originators ....................................................................................................................................... 748


Clinical Data: .................................................................................................................................... 748

259) GRASS POLLEN IMMUNOTHERAPY ......................................................................................... 750

Summary ......................................................................................................................................... 751

Originators ....................................................................................................................................... 751


Clinical Data: .................................................................................................................................... 751

260) GROWTH HORMONE ............................................................................................................... 753

Summary ......................................................................................................................................... 753

Originators ....................................................................................................................................... 753


Clinical Data: .................................................................................................................................... 754

261) GS-101 ..................................................................................................................................... 756

Summary ......................................................................................................................................... 756

Originators ....................................................................................................................................... 756


Clinical Data: .................................................................................................................................... 756

262) GV-1001 ................................................................................................................................... 758

Summary ......................................................................................................................................... 758

Originators ....................................................................................................................................... 758


Clinical Data: .................................................................................................................................... 759

263) GW-1000 .................................................................................................................................. 761

Summary ......................................................................................................................................... 761

Originators ....................................................................................................................................... 761


Clinical Data: .................................................................................................................................... 761

264) GW-406381.............................................................................................................................. 763

Summary ......................................................................................................................................... 763


Originators ....................................................................................................................................... 764


Clinical Data: .................................................................................................................................... 764

265) HAEMOPHILUS INFLUENZAE B VACCINE ................................................................................. 766

Summary ......................................................................................................................................... 766

Originators ....................................................................................................................................... 766


Clinical Data: .................................................................................................................................... 766

266) HBV-ISS .................................................................................................................................... 768

Summary ......................................................................................................................................... 768

Originators ....................................................................................................................................... 769


Clinical Data: .................................................................................................................................... 769

267) HEMATIDE ............................................................................................................................... 771

Summary ......................................................................................................................................... 771

Originators ....................................................................................................................................... 771


Clinical Data: .................................................................................................................................... 771

268) HEMOSPAN .............................................................................................................................. 773

Summary ......................................................................................................................................... 774

Originators ....................................................................................................................................... 774


Clinical Data: .................................................................................................................................... 774

269) HEPATITIS B VACCINE .............................................................................................................. 776

Summary ......................................................................................................................................... 776

Originators ....................................................................................................................................... 776


Clinical Data: .................................................................................................................................... 776

270) HFA NITROGLYCERIN SPRAY .................................................................................................... 778

Summary ......................................................................................................................................... 779

Originators ....................................................................................................................................... 779



Clinical Data: .................................................................................................................................... 779

271) HIB-MENCY-TT ......................................................................................................................... 781

Summary ......................................................................................................................................... 781

Originators ....................................................................................................................................... 781


Clinical Data: .................................................................................................................................... 782

272) HIGH RATIO THC ...................................................................................................................... 784

Summary ......................................................................................................................................... 784

Originators ....................................................................................................................................... 784


Clinical Data: .................................................................................................................................... 784

273) HR5I ......................................................................................................................................... 786

Summary ......................................................................................................................................... 786

Originators ....................................................................................................................................... 786


Clinical Data: .................................................................................................................................... 787

274) HRA-052015 ............................................................................................................................. 789

Summary ......................................................................................................................................... 789

Originators ....................................................................................................................................... 789


Clinical Data: .................................................................................................................................... 789

275) HUMAN FGF1 GENE THERAPY ................................................................................................. 791

Summary ......................................................................................................................................... 791

Originators ....................................................................................................................................... 792


Clinical Data: .................................................................................................................................... 792

276) HUMAX-EGFR .......................................................................................................................... 794

Summary ......................................................................................................................................... 794

Originators ....................................................................................................................................... 794


Clinical Data: .................................................................................................................................... 794

277) HYDROCODONE BITARTRATE (CONTROLLED RELEASE) .......................................................... 796


Summary ......................................................................................................................................... 796

Originators ....................................................................................................................................... 797


Clinical Data: .................................................................................................................................... 797

278) HYDROMORPHONE HYDROCHLORIDE .................................................................................... 799

Summary ......................................................................................................................................... 799

Originators ....................................................................................................................................... 799


Clinical Data: .................................................................................................................................... 799

279) HYLASTAN ................................................................................................................................ 801

Summary ......................................................................................................................................... 802

Originators ....................................................................................................................................... 802


Clinical Data: .................................................................................................................................... 802

280) HYPERACUTE PANCREAS ......................................................................................................... 804

Summary ......................................................................................................................................... 804

Originators ....................................................................................................................................... 804


Clinical Data: .................................................................................................................................... 804

281) IBUPROFEN .............................................................................................................................. 806

Summary ......................................................................................................................................... 807

Originators ....................................................................................................................................... 807


Clinical Data: .................................................................................................................................... 807

282) IBUPROFEN + FAMOTIDINE ..................................................................................................... 809

Summary ......................................................................................................................................... 809

Originators ....................................................................................................................................... 809


Clinical Data: .................................................................................................................................... 810

283) IBUPROFEN + PHOSPHATIDYLCHOLINE ................................................................................... 812

Summary ......................................................................................................................................... 812

Originators ....................................................................................................................................... 812



Clinical Data: .................................................................................................................................... 812

284) ICX-PRO .................................................................................................................................... 814

Summary ......................................................................................................................................... 814

Originators ....................................................................................................................................... 814


Clinical Data: .................................................................................................................................... 815

285) IDM-2 ....................................................................................................................................... 817

Summary ......................................................................................................................................... 817

Originators ....................................................................................................................................... 817


Clinical Data: .................................................................................................................................... 817

286) IDP-108 .................................................................................................................................... 819

Summary ......................................................................................................................................... 819

Originators ....................................................................................................................................... 820


Clinical Data: .................................................................................................................................... 820

287) IDP-115 .................................................................................................................................... 822

Summary ......................................................................................................................................... 822

Originators ....................................................................................................................................... 822


Clinical Data: .................................................................................................................................... 822

288) IDRAPARINUX SODIUM ........................................................................................................... 824

Summary ......................................................................................................................................... 824

Originators ....................................................................................................................................... 825


Clinical Data: .................................................................................................................................... 825

289) IGN-101.................................................................................................................................... 827

Summary ......................................................................................................................................... 827

Originators ....................................................................................................................................... 827


Clinical Data: .................................................................................................................................... 827


290) IGURATIMOD (SIMCERE) ......................................................................................................... 829

Summary ......................................................................................................................................... 830

Originators ....................................................................................................................................... 830


Clinical Data: .................................................................................................................................... 830

291) IMC-1121B ............................................................................................................................... 832

Summary ......................................................................................................................................... 832

Originators ....................................................................................................................................... 832


Clinical Data: .................................................................................................................................... 832

292) IMMUNE GLOBULIN INTRAVENOUS (HUMAN) ....................................................................... 834

Summary ......................................................................................................................................... 835

Originators ....................................................................................................................................... 835


Clinical Data: .................................................................................................................................... 835

293) INFLUENZA VACCINE ............................................................................................................... 837

Summary ......................................................................................................................................... 837

Originators ....................................................................................................................................... 837


Clinical Data: .................................................................................................................................... 838

294) INFLUENZA VACCINE (CELL CULTURE) ..................................................................................... 840

Summary ......................................................................................................................................... 840

Originators ....................................................................................................................................... 840


Clinical Data: .................................................................................................................................... 840

295) INGENOL MEBUTATE ............................................................................................................... 842

Summary ......................................................................................................................................... 842

Originators ....................................................................................................................................... 842


Clinical Data: .................................................................................................................................... 843

296) INGN-241 ................................................................................................................................. 845

Summary ......................................................................................................................................... 845


Originators ....................................................................................................................................... 845


Clinical Data: .................................................................................................................................... 845

297) INHALED DIHYDROERGOTAMINE ............................................................................................ 847

Summary ......................................................................................................................................... 847

Originators ....................................................................................................................................... 848


Clinical Data: .................................................................................................................................... 848

298) INHALED FENTANYL ................................................................................................................. 850

Summary ......................................................................................................................................... 850

Originators ....................................................................................................................................... 850


Clinical Data: .................................................................................................................................... 850

299) INHALED TREPROSTINIL ........................................................................................................... 852

Summary ......................................................................................................................................... 852

Originators ....................................................................................................................................... 853


Clinical Data: .................................................................................................................................... 853

300) INSULIN INHALED (RECOMBINANT HUMAN INSULIN) ............................................................ 855

Summary ......................................................................................................................................... 855

Originators ....................................................................................................................................... 855


Clinical Data: .................................................................................................................................... 855

301) INTERFERON ALFA-N1 ............................................................................................................. 857

Summary ......................................................................................................................................... 858

Originators ....................................................................................................................................... 858


Clinical Data: .................................................................................................................................... 858

302) INTERFERON ALFA-N3 (INJECTION) ......................................................................................... 860

Summary ......................................................................................................................................... 860

Originators ....................................................................................................................................... 860



Clinical Data: .................................................................................................................................... 860

303) INTERFERON ALFA-N3 (ORAL) ................................................................................................. 862

Summary ......................................................................................................................................... 863

Originators ....................................................................................................................................... 863


Clinical Data: .................................................................................................................................... 863

304) INTERFERON BETA-1A ............................................................................................................. 865

Summary ......................................................................................................................................... 865

Originators ....................................................................................................................................... 865


Clinical Data: .................................................................................................................................... 866

305) INTRANASAL KETAMINE .......................................................................................................... 868

Summary ......................................................................................................................................... 868

Originators ....................................................................................................................................... 868


Clinical Data: .................................................................................................................................... 868

306) IOGEN ...................................................................................................................................... 870

Summary ......................................................................................................................................... 870

Originators ....................................................................................................................................... 870


Clinical Data: .................................................................................................................................... 871

307) IOR T1 ANTIBODY .................................................................................................................... 873

Summary ......................................................................................................................................... 873

Originators ....................................................................................................................................... 873


Clinical Data: .................................................................................................................................... 873

308) IOSIMENOL .............................................................................................................................. 875

Summary ......................................................................................................................................... 875

Originators ....................................................................................................................................... 876


Clinical Data: .................................................................................................................................... 876

309) IPILIMUMAB ............................................................................................................................ 878


Summary ......................................................................................................................................... 878

Originators ....................................................................................................................................... 878


Clinical Data: .................................................................................................................................... 878

310) IRBESARTAN............................................................................................................................. 880

Summary ......................................................................................................................................... 880

Originators ....................................................................................................................................... 881


Clinical Data: .................................................................................................................................... 881

311) ISAVUCONAZOLE ..................................................................................................................... 883

Summary ......................................................................................................................................... 883

Originators ....................................................................................................................................... 883


Clinical Data: .................................................................................................................................... 883

312) ITRACONAZOLE ........................................................................................................................ 885

Summary ......................................................................................................................................... 886

Originators ....................................................................................................................................... 886


Clinical Data: .................................................................................................................................... 886

313) IXOC-2 ...................................................................................................................................... 888

Summary ......................................................................................................................................... 888

Originators ....................................................................................................................................... 888


Clinical Data: .................................................................................................................................... 888

314) JAK2 TYROSINE KINASE INHIBITORS ........................................................................................ 890

Summary ......................................................................................................................................... 891

Originators ....................................................................................................................................... 891


Clinical Data: .................................................................................................................................... 891

315) JR-013 ...................................................................................................................................... 893

Summary ......................................................................................................................................... 893

Originators ....................................................................................................................................... 893



Clinical Data: .................................................................................................................................... 894

316) JRF-8909 .................................................................................................................................. 896

Summary ......................................................................................................................................... 896

Originators ....................................................................................................................................... 896


Clinical Data: .................................................................................................................................... 896

317) KETOCONAZOLE + DESONIDE .................................................................................................. 898

Summary ......................................................................................................................................... 898

Originators ....................................................................................................................................... 898


Clinical Data: .................................................................................................................................... 899

318) KLH ........................................................................................................................................... 901

Summary ......................................................................................................................................... 901

Originators ....................................................................................................................................... 901


Clinical Data: .................................................................................................................................... 901

319) KP-102 PROGRAM ................................................................................................................... 903

Summary ......................................................................................................................................... 903

Originators ....................................................................................................................................... 904


Clinical Data: .................................................................................................................................... 904

320) KREMEZIN ................................................................................................................................ 906

Summary ......................................................................................................................................... 906

Originators ....................................................................................................................................... 906


Clinical Data: .................................................................................................................................... 906

321) LACOSAMIDE ........................................................................................................................... 908

Summary ......................................................................................................................................... 908

Originators ....................................................................................................................................... 909


Clinical Data: .................................................................................................................................... 909


322) LANTHANUM CARBONATE ...................................................................................................... 911

Summary ......................................................................................................................................... 911

Originators ....................................................................................................................................... 911


Clinical Data: .................................................................................................................................... 911

323) LAQUINIMOD ........................................................................................................................... 913

Summary ......................................................................................................................................... 914

Originators ....................................................................................................................................... 914


Clinical Data: .................................................................................................................................... 914

324) LAS-34475 ................................................................................................................................ 916

Summary ......................................................................................................................................... 916

Originators ....................................................................................................................................... 916


Clinical Data: .................................................................................................................................... 916

325) LATANOPROST + TIMOLOL ...................................................................................................... 918

Summary ......................................................................................................................................... 919

Originators ....................................................................................................................................... 919


Clinical Data: .................................................................................................................................... 919

326) LAX-101 .................................................................................................................................... 921

Summary ......................................................................................................................................... 921

Originators ....................................................................................................................................... 921


Clinical Data: .................................................................................................................................... 922

327) LDI-200..................................................................................................................................... 924

Summary ......................................................................................................................................... 924

Originators ....................................................................................................................................... 924


Clinical Data: .................................................................................................................................... 924

328) LESTAURTINIB .......................................................................................................................... 926

Summary ......................................................................................................................................... 926


Originators ....................................................................................................................................... 926


Clinical Data: .................................................................................................................................... 927

329) LEUPROLIDE ACETATE IMPLANT (CNS) .................................................................................... 929

Summary ......................................................................................................................................... 929

Originators ....................................................................................................................................... 929


Clinical Data: .................................................................................................................................... 929

330) LEVOFOLINIC ACID ................................................................................................................... 931

Summary ......................................................................................................................................... 931

Originators ....................................................................................................................................... 932


Clinical Data: .................................................................................................................................... 932

331) LEXIPAFANT (IV FORMULATION) ............................................................................................. 934

Summary ......................................................................................................................................... 934

Originators ....................................................................................................................................... 934


Clinical Data: .................................................................................................................................... 934

332) LIAROZOLE ............................................................................................................................... 936

Summary ......................................................................................................................................... 936

Originators ....................................................................................................................................... 937


Clinical Data: .................................................................................................................................... 937

333) LICARBAZEPINE ........................................................................................................................ 939

Summary ......................................................................................................................................... 939

Originators ....................................................................................................................................... 939


Clinical Data: .................................................................................................................................... 939

334) LIDOCAINE ............................................................................................................................... 941

Summary ......................................................................................................................................... 942

Originators ....................................................................................................................................... 942



Clinical Data: .................................................................................................................................... 942

335) LIDOCAINE PATCH ................................................................................................................... 944

Summary ......................................................................................................................................... 944

Originators ....................................................................................................................................... 944


Clinical Data: .................................................................................................................................... 944

336) LIDOCAINE TRANSDERMAL PATCH .......................................................................................... 946

Summary ......................................................................................................................................... 947

Originators ....................................................................................................................................... 947


Clinical Data: .................................................................................................................................... 947

337) LIDOCAINE; PRILOCAINE .......................................................................................................... 949

Summary ......................................................................................................................................... 949

Originators ....................................................................................................................................... 949


Clinical Data: .................................................................................................................................... 950

338) LINACLOTIDE ............................................................................................................................ 952

Summary ......................................................................................................................................... 952

Originators ....................................................................................................................................... 952


Clinical Data: .................................................................................................................................... 952

339) LIPOSOMAL CISPLATIN ............................................................................................................ 954

Summary ......................................................................................................................................... 954

Originators ....................................................................................................................................... 954


Clinical Data: .................................................................................................................................... 955

340) LIPROTAMASE .......................................................................................................................... 957

Summary ......................................................................................................................................... 957

Originators ....................................................................................................................................... 957


Clinical Data: .................................................................................................................................... 957

341) LISURIDE .................................................................................................................................. 959


Summary ......................................................................................................................................... 959

Originators ....................................................................................................................................... 960


Clinical Data: .................................................................................................................................... 960

342) LITX .......................................................................................................................................... 962

Summary ......................................................................................................................................... 962

Originators ....................................................................................................................................... 962


Clinical Data: .................................................................................................................................... 962

343) LIXISENATIDE ........................................................................................................................... 964

Summary ......................................................................................................................................... 964

Originators ....................................................................................................................................... 965


Clinical Data: .................................................................................................................................... 965

344) LIXIVAPTAN .............................................................................................................................. 967

Summary ......................................................................................................................................... 967

Originators ....................................................................................................................................... 967


Clinical Data: .................................................................................................................................... 967

345) LOFEXIDINE .............................................................................................................................. 969

Summary ......................................................................................................................................... 970

Originators ....................................................................................................................................... 970


Clinical Data: .................................................................................................................................... 970

346) LOMITAPIDE ............................................................................................................................ 972

Summary ......................................................................................................................................... 972

Originators ....................................................................................................................................... 972


Clinical Data: .................................................................................................................................... 972

347) LONAFARNIB ............................................................................................................................ 974

Summary ......................................................................................................................................... 975

Originators ....................................................................................................................................... 975



Clinical Data: .................................................................................................................................... 975

348) LOSIGAMONE .......................................................................................................................... 977

Summary ......................................................................................................................................... 977

Originators ....................................................................................................................................... 977


Clinical Data: .................................................................................................................................... 978

349) LU-AA21004 ............................................................................................................................. 980

Summary ......................................................................................................................................... 980

Originators ....................................................................................................................................... 980


Clinical Data: .................................................................................................................................... 980

350) LUBIPROSTONE ........................................................................................................................ 982

Summary ......................................................................................................................................... 982

Originators ....................................................................................................................................... 982


Clinical Data: .................................................................................................................................... 983

351) LURASIDONE ............................................................................................................................ 985

Summary ......................................................................................................................................... 985

Originators ....................................................................................................................................... 985


Clinical Data: .................................................................................................................................... 985

352) LUSUPULTIDE ........................................................................................................................... 987

Summary ......................................................................................................................................... 987

Originators ....................................................................................................................................... 988


Clinical Data: .................................................................................................................................... 988

353) LX-201 ...................................................................................................................................... 990

Summary ......................................................................................................................................... 990

Originators ....................................................................................................................................... 990


Clinical Data: .................................................................................................................................... 990


354) LY-544344 ................................................................................................................................ 992

Summary ......................................................................................................................................... 992

Originators ....................................................................................................................................... 993


Clinical Data: .................................................................................................................................... 993

355) LYMPHATIC TARGETING AGENT .............................................................................................. 995

Summary ......................................................................................................................................... 995

Originators ....................................................................................................................................... 995


Clinical Data: .................................................................................................................................... 995

356) LYMPHOSCAN .......................................................................................................................... 997

Summary ......................................................................................................................................... 998

Originators ....................................................................................................................................... 998


Clinical Data: .................................................................................................................................... 998

357) MAGE-A3 ANTIGEN-SPECIFIC CANCER .................................................................................. 1000

Summary ....................................................................................................................................... 1000

Originators ..................................................................................................................................... 1000

Licensing and General info: ........................................................................................................... 1000

Clinical Data: .................................................................................................................................. 1000

358) MASILUKAST .......................................................................................................................... 1002

Summary ....................................................................................................................................... 1003

Originators ..................................................................................................................................... 1003


Clinical Data: .................................................................................................................................. 1003

359) MASITINIB .............................................................................................................................. 1005

Summary ....................................................................................................................................... 1005

Originators ..................................................................................................................................... 1005


Clinical Data: .................................................................................................................................. 1006

360) MBX-102 ................................................................................................................................ 1008

Summary ....................................................................................................................................... 1008


Originators ..................................................................................................................................... 1008


Clinical Data: .................................................................................................................................. 1008

361) MC-1 ...................................................................................................................................... 1010

Summary ....................................................................................................................................... 1010

Originators ..................................................................................................................................... 1010


Clinical Data: .................................................................................................................................. 1011

362) MDI-403 ................................................................................................................................. 1013

Summary ....................................................................................................................................... 1013

Originators ..................................................................................................................................... 1013


Clinical Data: .................................................................................................................................. 1013

363) MDV-3100 ............................................................................................................................. 1015

Summary ....................................................................................................................................... 1015

Originators ..................................................................................................................................... 1016


Clinical Data: .................................................................................................................................. 1016

364) MDX-1379 .............................................................................................................................. 1018

Summary ....................................................................................................................................... 1018

Originators ..................................................................................................................................... 1018


Clinical Data: .................................................................................................................................. 1018

365) MECLORETHAMINE ............................................................................................................... 1020

Summary ....................................................................................................................................... 1020

Originators ..................................................................................................................................... 1021


Clinical Data: .................................................................................................................................. 1021

366) MEDIDUR ............................................................................................................................... 1023

Summary ....................................................................................................................................... 1023

Originators ..................................................................................................................................... 1023



Clinical Data: .................................................................................................................................. 1023

367) MELANOMA VACCINE (NEW YORK UNIVERSITY) .................................................................. 1025

Summary ....................................................................................................................................... 1026

Originators ..................................................................................................................................... 1026


Clinical Data: .................................................................................................................................. 1026

368) MEMANTINE HYDROCHLORIDE ............................................................................................. 1028

Summary ....................................................................................................................................... 1028

Originators ..................................................................................................................................... 1028


Clinical Data: .................................................................................................................................. 1028

369) MENINGOCOCCAL VACCINE .................................................................................................. 1030

Summary ....................................................................................................................................... 1031

Originators ..................................................................................................................................... 1031


Clinical Data: .................................................................................................................................. 1031

370) MESALAMINE......................................................................................................................... 1033

Summary ....................................................................................................................................... 1033

Originators ..................................................................................................................................... 1033


Clinical Data: .................................................................................................................................. 1034

371) MESENCHYMAL STEM CELL THERAPY ................................................................................... 1036

Summary ....................................................................................................................................... 1036

Originators ..................................................................................................................................... 1036


Clinical Data: .................................................................................................................................. 1036

372) MICONAZOLE NITRATE .......................................................................................................... 1038

Summary ....................................................................................................................................... 1038

Originators ..................................................................................................................................... 1038


Clinical Data: .................................................................................................................................. 1039

373) MIDAZOLAM (INTRANASAL), INTRANASAL ........................................................................... 1041


Summary ....................................................................................................................................... 1041

Originators ..................................................................................................................................... 1041


Clinical Data: .................................................................................................................................. 1041

374) MIDGE IMMUNOMODULATOR ............................................................................................. 1043

Summary ....................................................................................................................................... 1043

Originators ..................................................................................................................................... 1044


Clinical Data: .................................................................................................................................. 1044

375) MIFEPRISTONE ....................................................................................................................... 1046

Summary ....................................................................................................................................... 1046

Originators ..................................................................................................................................... 1046


Clinical Data: .................................................................................................................................. 1046

376) MIPOMERSEN SODIUM ......................................................................................................... 1048

Summary ....................................................................................................................................... 1048

Originators ..................................................................................................................................... 1049


Clinical Data: .................................................................................................................................. 1049

377) MITGLINIDE + METFORMIN ................................................................................................... 1051

Summary ....................................................................................................................................... 1051

Originators ..................................................................................................................................... 1051


Clinical Data: .................................................................................................................................. 1051

378) MITIGLINIDE CALCIUM HYDRATE .......................................................................................... 1053

Summary ....................................................................................................................................... 1054

Originators ..................................................................................................................................... 1054


Clinical Data: .................................................................................................................................. 1054

379) MK-677 .................................................................................................................................. 1056

Summary ....................................................................................................................................... 1056

Originators ..................................................................................................................................... 1056



Clinical Data: .................................................................................................................................. 1056

380) MN-001 .................................................................................................................................. 1058

Summary ....................................................................................................................................... 1059

Originators ..................................................................................................................................... 1059


Clinical Data: .................................................................................................................................. 1059

381) MN-305 .................................................................................................................................. 1061

Summary ....................................................................................................................................... 1061

Originators ..................................................................................................................................... 1061


Clinical Data: .................................................................................................................................. 1062

382) MORPHINE + OXYCODONE .................................................................................................... 1064

Summary ....................................................................................................................................... 1064

Originators ..................................................................................................................................... 1064


Clinical Data: .................................................................................................................................. 1064

383) MORPHINE SULFATE .............................................................................................................. 1066

Summary ....................................................................................................................................... 1066

Originators ..................................................................................................................................... 1066


Clinical Data: .................................................................................................................................. 1067

384) MOXIFLOXACIN ...................................................................................................................... 1069

Summary ....................................................................................................................................... 1069

Originators ..................................................................................................................................... 1069


Clinical Data: .................................................................................................................................. 1069

385) MPC-6827 .............................................................................................................................. 1071

Summary ....................................................................................................................................... 1071

Originators ..................................................................................................................................... 1072


Clinical Data: .................................................................................................................................. 1072


386) MPL-CONTAINING POLLINEX ALLERGY .................................................................................. 1074

Summary ....................................................................................................................................... 1074

Originators ..................................................................................................................................... 1074


Clinical Data: .................................................................................................................................. 1074

387) MQX-503 ............................................................................................................................... 1076

Summary ....................................................................................................................................... 1076

Originators ..................................................................................................................................... 1077


Clinical Data: .................................................................................................................................. 1077

388) MRX-1024 .............................................................................................................................. 1079

Summary ....................................................................................................................................... 1079

Originators ..................................................................................................................................... 1079


Clinical Data: .................................................................................................................................. 1079

389) MYCOBACTERIAL CELL WALL-DNA COMPLEX ....................................................................... 1081

Summary ....................................................................................................................................... 1082

Originators ..................................................................................................................................... 1082


Clinical Data: .................................................................................................................................. 1082

390) MYCOPHENOLATE MOFETIL .................................................................................................. 1084

Summary ....................................................................................................................................... 1084

Originators ..................................................................................................................................... 1084


Clinical Data: .................................................................................................................................. 1084

391) NALMEFENE ........................................................................................................................... 1086

Summary ....................................................................................................................................... 1087

Originators ..................................................................................................................................... 1087


Clinical Data: .................................................................................................................................. 1087

392) NEMORUBICIN ....................................................................................................................... 1089

Summary ....................................................................................................................................... 1089


Originators ..................................................................................................................................... 1089


Clinical Data: .................................................................................................................................. 1090

393) NERAMEXANE ........................................................................................................................ 1092

Summary ....................................................................................................................................... 1092

Originators ..................................................................................................................................... 1092


Clinical Data: .................................................................................................................................. 1092

394) NERVE REGENERATION TEMPLATES ..................................................................................... 1094

Summary ....................................................................................................................................... 1094

Originators ..................................................................................................................................... 1094


Clinical Data: .................................................................................................................................. 1095

395) NESTORONE + ESTRADIOL GEL .............................................................................................. 1097

Summary ....................................................................................................................................... 1097

Originators ..................................................................................................................................... 1097


Clinical Data: .................................................................................................................................. 1097

396) NICVAX ................................................................................................................................... 1099

Summary ....................................................................................................................................... 1099

Originators ..................................................................................................................................... 1100


Clinical Data: .................................................................................................................................. 1100

397) NIMOTUZUMAB .................................................................................................................... 1102

Summary ....................................................................................................................................... 1102

Originators ..................................................................................................................................... 1102


Clinical Data: .................................................................................................................................. 1102

398) NOFERTIL ............................................................................................................................... 1104

Summary ....................................................................................................................................... 1104

Originators ..................................................................................................................................... 1105



Clinical Data: .................................................................................................................................. 1105

399) NOLOMIROLE ......................................................................................................................... 1107

Summary ....................................................................................................................................... 1107

Originators ..................................................................................................................................... 1107


Clinical Data: .................................................................................................................................. 1107

400) NOV-002 ................................................................................................................................ 1109

Summary ....................................................................................................................................... 1110

Originators ..................................................................................................................................... 1110


Clinical Data: .................................................................................................................................. 1110

401) NS-126 ................................................................................................................................... 1112

Summary ....................................................................................................................................... 1112

Originators ..................................................................................................................................... 1112


Clinical Data: .................................................................................................................................. 1112

402) NT-501 ................................................................................................................................... 1114

Summary ....................................................................................................................................... 1115

Originators ..................................................................................................................................... 1115


Clinical Data: .................................................................................................................................. 1115

403) NUMAX .................................................................................................................................. 1117

Summary ....................................................................................................................................... 1117

Originators ..................................................................................................................................... 1117


Clinical Data: .................................................................................................................................. 1118

404) NWP-06 ................................................................................................................................. 1120

Summary ....................................................................................................................................... 1120

Originators ..................................................................................................................................... 1120


Clinical Data: .................................................................................................................................. 1120

405) NX-1207 ................................................................................................................................. 1122


Summary ....................................................................................................................................... 1122

Originators ..................................................................................................................................... 1122


Clinical Data: .................................................................................................................................. 1123

406) OCTAFLUOROPROPANE ......................................................................................................... 1125

Summary ....................................................................................................................................... 1125

Originators ..................................................................................................................................... 1125


Clinical Data: .................................................................................................................................. 1125

407) OCTREOTIDE .......................................................................................................................... 1127

Summary ....................................................................................................................................... 1127

Originators ..................................................................................................................................... 1128


Clinical Data: .................................................................................................................................. 1128

408) OCTREOTIDE SUSTAINED RELEASE IMPLANT ........................................................................ 1130

Summary ....................................................................................................................................... 1130

Originators ..................................................................................................................................... 1130


Clinical Data: .................................................................................................................................. 1130

409) ODANACATIB ......................................................................................................................... 1132

Summary ....................................................................................................................................... 1132

Originators ..................................................................................................................................... 1133


Clinical Data: .................................................................................................................................. 1133

410) OGX-011 ................................................................................................................................ 1135

Summary ....................................................................................................................................... 1135

Originators ..................................................................................................................................... 1135


Clinical Data: .................................................................................................................................. 1135

411) OMACOR ................................................................................................................................ 1137

Summary ....................................................................................................................................... 1138

Originators ..................................................................................................................................... 1138



Clinical Data: .................................................................................................................................. 1138

412) OMALIZUMAB ........................................................................................................................ 1140

Summary ....................................................................................................................................... 1140

Originators ..................................................................................................................................... 1140


Clinical Data: .................................................................................................................................. 1140

413) OMEPRAZOLE ........................................................................................................................ 1142

Summary ....................................................................................................................................... 1143

Originators ..................................................................................................................................... 1143


Clinical Data: .................................................................................................................................. 1143

414) OMIGANAN ............................................................................................................................ 1145

Summary ....................................................................................................................................... 1145

Originators ..................................................................................................................................... 1145


Clinical Data: .................................................................................................................................. 1146

415) OMS-103HP ........................................................................................................................... 1148

Summary ....................................................................................................................................... 1148

Originators ..................................................................................................................................... 1148


Clinical Data: .................................................................................................................................. 1148

416) ONCOVAX .............................................................................................................................. 1150

Summary ....................................................................................................................................... 1150

Originators ..................................................................................................................................... 1150


Clinical Data: .................................................................................................................................. 1151

417) ONCOVEX GM-CSF ................................................................................................................. 1153

Summary ....................................................................................................................................... 1153

Originators ..................................................................................................................................... 1153


Clinical Data: .................................................................................................................................. 1153


418) ONDANSETRON ..................................................................................................................... 1155

Summary ....................................................................................................................................... 1155

Originators ..................................................................................................................................... 1156


Clinical Data: .................................................................................................................................. 1156

419) ONO-2506 .............................................................................................................................. 1158

Summary ....................................................................................................................................... 1158

Originators ..................................................................................................................................... 1158


Clinical Data: .................................................................................................................................. 1158

420) OPC-31260 ............................................................................................................................. 1160

Summary ....................................................................................................................................... 1160

Originators ..................................................................................................................................... 1161


Clinical Data: .................................................................................................................................. 1161

421) OPEBACAN ............................................................................................................................. 1163

Summary ....................................................................................................................................... 1163

Originators ..................................................................................................................................... 1163


Clinical Data: .................................................................................................................................. 1163

422) ORAL ACYCLOVIR ................................................................................................................... 1165

Summary ....................................................................................................................................... 1166

Originators ..................................................................................................................................... 1166


Clinical Data: .................................................................................................................................. 1166

423) ORAL CYSTEINE ...................................................................................................................... 1168

Summary ....................................................................................................................................... 1168

Originators ..................................................................................................................................... 1168


Clinical Data: .................................................................................................................................. 1168

424) ORAL FLUPIRTINE .................................................................................................................. 1170

Summary ....................................................................................................................................... 1171


Originators ..................................................................................................................................... 1171


Clinical Data: .................................................................................................................................. 1171

425) ORAL SALMON CALCITONIN .................................................................................................. 1173

Summary ....................................................................................................................................... 1173

Originators ..................................................................................................................................... 1173


Clinical Data: .................................................................................................................................. 1174

426) ORAL TREPROSTINIL .............................................................................................................. 1176

Summary ....................................................................................................................................... 1176

Originators ..................................................................................................................................... 1176


Clinical Data: .................................................................................................................................. 1176

427) ORG-32818 ............................................................................................................................ 1178

Summary ....................................................................................................................................... 1178

Originators ..................................................................................................................................... 1178


Clinical Data: .................................................................................................................................. 1179

428) ORG-50081 ............................................................................................................................ 1181

Summary ....................................................................................................................................... 1181

Originators ..................................................................................................................................... 1181


Clinical Data: .................................................................................................................................. 1181

429) OSI-906 .................................................................................................................................. 1183

Summary ....................................................................................................................................... 1183

Originators ..................................................................................................................................... 1184


Clinical Data: .................................................................................................................................. 1184

430) OSPEMIFENE .......................................................................................................................... 1186

Summary ....................................................................................................................................... 1186

Originators ..................................................................................................................................... 1186



Clinical Data: .................................................................................................................................. 1186

431) OTELIXIZUMAB ...................................................................................................................... 1188

Summary ....................................................................................................................................... 1188

Originators ..................................................................................................................................... 1189


Clinical Data: .................................................................................................................................. 1189

432) OXCARBAZEPINE .................................................................................................................... 1191

Summary ....................................................................................................................................... 1191

Originators ..................................................................................................................................... 1191


Clinical Data: .................................................................................................................................. 1191

433) OXYCODONE + NALOXONE .................................................................................................... 1193

Summary ....................................................................................................................................... 1194

Originators ..................................................................................................................................... 1194


Clinical Data: .................................................................................................................................. 1194

434) OXYCODONE + NALTREXONE ................................................................................................ 1196

Summary ....................................................................................................................................... 1196

Originators ..................................................................................................................................... 1196


Clinical Data: .................................................................................................................................. 1197

435) OZAGREL SODIUM ................................................................................................................. 1199

Summary ....................................................................................................................................... 1199

Originators ..................................................................................................................................... 1199


Clinical Data: .................................................................................................................................. 1199

436) PACLITAXEL ............................................................................................................................ 1201

Summary ....................................................................................................................................... 1201

Originators ..................................................................................................................................... 1202


Clinical Data: .................................................................................................................................. 1202

437) PACLITAXEL NP ...................................................................................................................... 1204


Summary ....................................................................................................................................... 1204

Originators ..................................................................................................................................... 1204


Clinical Data: .................................................................................................................................. 1204

438) PACLITAXEL POLIGLUMEX ..................................................................................................... 1206

Summary ....................................................................................................................................... 1207

Originators ..................................................................................................................................... 1207


Clinical Data: .................................................................................................................................. 1207

439) PALIFOSFAMIDE ..................................................................................................................... 1209

Summary ....................................................................................................................................... 1209

Originators ..................................................................................................................................... 1209


Clinical Data: .................................................................................................................................. 1210

440) PANCRELIPASE (AMYLASE + LIPASE + PROTEASE) ................................................................. 1212

Summary ....................................................................................................................................... 1212

Originators ..................................................................................................................................... 1212


Clinical Data: .................................................................................................................................. 1212

441) PATUPILONE .......................................................................................................................... 1214

Summary ....................................................................................................................................... 1214

Originators ..................................................................................................................................... 1215


Clinical Data: .................................................................................................................................. 1215

442) PBF-1681 ................................................................................................................................ 1217

Summary ....................................................................................................................................... 1217

Originators ..................................................................................................................................... 1217


Clinical Data: .................................................................................................................................. 1217

443) PC-515 ................................................................................................................................... 1219

Summary ....................................................................................................................................... 1220

Originators ..................................................................................................................................... 1220



Clinical Data: .................................................................................................................................. 1220

444) PD-02 ..................................................................................................................................... 1222

Summary ....................................................................................................................................... 1222

Originators ..................................................................................................................................... 1222


Clinical Data: .................................................................................................................................. 1223

445) PEGYLATED INTERFERON BETA-1A ........................................................................................ 1225

Summary ....................................................................................................................................... 1225

Originators ..................................................................................................................................... 1225


Clinical Data: .................................................................................................................................. 1225

446) PELUBIPROFEN ...................................................................................................................... 1227

Summary ....................................................................................................................................... 1227

Originators ..................................................................................................................................... 1228


Clinical Data: .................................................................................................................................. 1228

447) PENTASTAPH ......................................................................................................................... 1230

Summary ....................................................................................................................................... 1230

Originators ..................................................................................................................................... 1230


Clinical Data: .................................................................................................................................. 1230

448) PERAMPANEL ........................................................................................................................ 1232

Summary ....................................................................................................................................... 1233

Originators ..................................................................................................................................... 1233


Clinical Data: .................................................................................................................................. 1233

449) PERETINOIN ........................................................................................................................... 1235

Summary ....................................................................................................................................... 1235

Originators ..................................................................................................................................... 1235


Clinical Data: .................................................................................................................................. 1236


450) PERFLUBUTANE ..................................................................................................................... 1238

Summary ....................................................................................................................................... 1238

Originators ..................................................................................................................................... 1238


Clinical Data: .................................................................................................................................. 1238

451) PERFOAM ............................................................................................................................... 1240

Summary ....................................................................................................................................... 1240

Originators ..................................................................................................................................... 1241


Clinical Data: .................................................................................................................................. 1241

452) PERIFOSINE ............................................................................................................................ 1243

Summary ....................................................................................................................................... 1243

Originators ..................................................................................................................................... 1243


Clinical Data: .................................................................................................................................. 1243

453) PERU-15 PCTB ........................................................................................................................ 1245

Summary ....................................................................................................................................... 1246

Originators ..................................................................................................................................... 1246


Clinical Data: .................................................................................................................................. 1246

454) PEXIGANAN ACETATE ............................................................................................................ 1248

Summary ....................................................................................................................................... 1248

Originators ..................................................................................................................................... 1248


Clinical Data: .................................................................................................................................. 1249

455) PGL-4001 ............................................................................................................................... 1251

Summary ....................................................................................................................................... 1251

Originators ..................................................................................................................................... 1251


Clinical Data: .................................................................................................................................. 1251

456) PHP-HT ................................................................................................................................... 1253

Summary ....................................................................................................................................... 1253


Originators ..................................................................................................................................... 1254


Clinical Data: .................................................................................................................................. 1254

457) PICOPLATIN............................................................................................................................ 1256

Summary ....................................................................................................................................... 1256

Originators ..................................................................................................................................... 1256


Clinical Data: .................................................................................................................................. 1256

458) PICOSULPHATE ...................................................................................................................... 1258

Summary ....................................................................................................................................... 1259

Originators ..................................................................................................................................... 1259


Clinical Data: .................................................................................................................................. 1259

459) PIMAVANSERIN TARTRATE .................................................................................................... 1261

Summary ....................................................................................................................................... 1261

Originators ..................................................................................................................................... 1261


Clinical Data: .................................................................................................................................. 1262

460) PIRFENIDONE ......................................................................................................................... 1264

Summary ....................................................................................................................................... 1264

Originators ..................................................................................................................................... 1264


Clinical Data: .................................................................................................................................. 1264

461) PN-401 ................................................................................................................................... 1266

Summary ....................................................................................................................................... 1266

Originators ..................................................................................................................................... 1267


Clinical Data: .................................................................................................................................. 1267

462) POLYCLONAL ANTIBODY STIMULATOR ................................................................................. 1269

Summary ....................................................................................................................................... 1269

Originators ..................................................................................................................................... 1269



Clinical Data: .................................................................................................................................. 1269

463) POVIDONE-IODINE ................................................................................................................ 1271

Summary ....................................................................................................................................... 1272

Originators ..................................................................................................................................... 1272


Clinical Data: .................................................................................................................................. 1272

464) PR1 PEPTIDE VACCINE ........................................................................................................... 1274

Summary ....................................................................................................................................... 1274

Originators ..................................................................................................................................... 1274


Clinical Data: .................................................................................................................................. 1275

465) PRAVASTATIN + FENOFIBRATE .............................................................................................. 1277

Summary ....................................................................................................................................... 1277

Originators ..................................................................................................................................... 1277


Clinical Data: .................................................................................................................................. 1277

466) PREDNISOLONE ..................................................................................................................... 1279

Summary ....................................................................................................................................... 1279

Originators ..................................................................................................................................... 1280


Clinical Data: .................................................................................................................................. 1280

467) PRO-2000 ............................................................................................................................... 1282

Summary ....................................................................................................................................... 1282

Originators ..................................................................................................................................... 1282


Clinical Data: .................................................................................................................................. 1282

468) PROCALYX .............................................................................................................................. 1284

Summary ....................................................................................................................................... 1285

Originators ..................................................................................................................................... 1285


Clinical Data: .................................................................................................................................. 1285

469) PROGESTERONE ..................................................................................................................... 1287


Summary ....................................................................................................................................... 1287

Originators ..................................................................................................................................... 1287


Clinical Data: .................................................................................................................................. 1288

470) PROGESTOGEN + ESTROGEN ................................................................................................. 1290

Summary ....................................................................................................................................... 1290

Originators ..................................................................................................................................... 1290


Clinical Data: .................................................................................................................................. 1290

471) PROPOFOL ............................................................................................................................. 1292

Summary ....................................................................................................................................... 1292

Originators ..................................................................................................................................... 1293


Clinical Data: .................................................................................................................................. 1293

472) PROPRANOLOL ...................................................................................................................... 1295

Summary ....................................................................................................................................... 1295

Originators ..................................................................................................................................... 1295


Clinical Data: .................................................................................................................................. 1295

473) PRUCALOPRIDE ...................................................................................................................... 1297

Summary ....................................................................................................................................... 1298

Originators ..................................................................................................................................... 1298


Clinical Data: .................................................................................................................................. 1298

474) PRULIFLOXACIN ..................................................................................................................... 1300

Summary ....................................................................................................................................... 1300

Originators ..................................................................................................................................... 1300


Clinical Data: .................................................................................................................................. 1301

475) PSD-502 ................................................................................................................................. 1303

Summary ....................................................................................................................................... 1303

Originators ..................................................................................................................................... 1303



Clinical Data: .................................................................................................................................. 1303

476) PTK-0796................................................................................................................................ 1305

Summary ....................................................................................................................................... 1305

Originators ..................................................................................................................................... 1306


Clinical Data: .................................................................................................................................. 1306

477) PYRIDOXAMINE ..................................................................................................................... 1308

Summary ....................................................................................................................................... 1308

Originators ..................................................................................................................................... 1308


Clinical Data: .................................................................................................................................. 1308

478) PYRONARIDINE; ARTESUNATE ............................................................................................... 1310

Summary ....................................................................................................................................... 1311

Originators ..................................................................................................................................... 1311


Clinical Data: .................................................................................................................................. 1311

479) QS-21 ..................................................................................................................................... 1313

Summary ....................................................................................................................................... 1313

Originators ..................................................................................................................................... 1313


Clinical Data: .................................................................................................................................. 1314

480) QVA-149 ................................................................................................................................ 1316

Summary ....................................................................................................................................... 1316

Originators ..................................................................................................................................... 1316


Clinical Data: .................................................................................................................................. 1316

481) R-HGH .................................................................................................................................... 1318

Summary ....................................................................................................................................... 1318

Originators ..................................................................................................................................... 1319


Clinical Data: .................................................................................................................................. 1319


482) RACOTUMOMAB ................................................................................................................... 1321

Summary ....................................................................................................................................... 1321

Originators ..................................................................................................................................... 1321


Clinical Data: .................................................................................................................................. 1321

483) RAGWEED EXTRACT ............................................................................................................... 1323

Summary ....................................................................................................................................... 1324

Originators ..................................................................................................................................... 1324


Clinical Data: .................................................................................................................................. 1324

484) RANPIRNASE .......................................................................................................................... 1326

Summary ....................................................................................................................................... 1326

Originators ..................................................................................................................................... 1326


Clinical Data: .................................................................................................................................. 1327

485) REBAMIPIDE (OPHTHALMIC) ................................................................................................. 1329

Summary ....................................................................................................................................... 1329

Originators ..................................................................................................................................... 1329


Clinical Data: .................................................................................................................................. 1329

486) RECOMBINANT G-CSF ............................................................................................................ 1331

Summary ....................................................................................................................................... 1331

Originators ..................................................................................................................................... 1332


Clinical Data: .................................................................................................................................. 1332

487) RECOMBINANT HUMAN MICROPLASMIN ............................................................................. 1334

Summary ....................................................................................................................................... 1334

Originators ..................................................................................................................................... 1334


Clinical Data: .................................................................................................................................. 1334

488) REGORAFENIB ........................................................................................................................ 1336

Summary ....................................................................................................................................... 1337


Originators ..................................................................................................................................... 1337


Clinical Data: .................................................................................................................................. 1337

489) RENZAPRIDE .......................................................................................................................... 1339

Summary ....................................................................................................................................... 1339

Originators ..................................................................................................................................... 1339


Clinical Data: .................................................................................................................................. 1340

490) REOLYSIN ............................................................................................................................... 1342

Summary ....................................................................................................................................... 1342

Originators ..................................................................................................................................... 1342


Clinical Data: .................................................................................................................................. 1342

491) RESLIZUMAB .......................................................................................................................... 1344

Summary ....................................................................................................................................... 1344

Originators ..................................................................................................................................... 1345


Clinical Data: .................................................................................................................................. 1345

492) RETASPIMYCIN HYDROCHLORIDE.......................................................................................... 1347

Summary ....................................................................................................................................... 1347

Originators ..................................................................................................................................... 1347


Clinical Data: .................................................................................................................................. 1347

493) RETIGABINE ........................................................................................................................... 1349

Summary ....................................................................................................................................... 1350

Originators ..................................................................................................................................... 1350


Clinical Data: .................................................................................................................................. 1350

494) REUMACON ........................................................................................................................... 1352

Summary ....................................................................................................................................... 1352

Originators ..................................................................................................................................... 1352



Clinical Data: .................................................................................................................................. 1353

495) REVIMMUNE .......................................................................................................................... 1355

Summary ....................................................................................................................................... 1355

Originators ..................................................................................................................................... 1355


Clinical Data: .................................................................................................................................. 1355

496) RG-1068 ................................................................................................................................. 1357

Summary ....................................................................................................................................... 1357

Originators ..................................................................................................................................... 1358


Clinical Data: .................................................................................................................................. 1358

497) RIBAVIRIN .............................................................................................................................. 1360

Summary ....................................................................................................................................... 1360

Originators ..................................................................................................................................... 1360


Clinical Data: .................................................................................................................................. 1360

498) RIDAFOROLIMUS ................................................................................................................... 1362

Summary ....................................................................................................................................... 1363

Originators ..................................................................................................................................... 1363


Clinical Data: .................................................................................................................................. 1363

499) RIFABUTIN + AMOXYCILLIN+ PANTOPRAZOLE ...................................................................... 1365

Summary ....................................................................................................................................... 1365

Originators ..................................................................................................................................... 1365


Clinical Data: .................................................................................................................................. 1366

500) RIFABUTIN + CLARITHROMYCIN + CLOFAZIMINE .................................................................. 1368

Summary ....................................................................................................................................... 1368

Originators ..................................................................................................................................... 1368


Clinical Data: .................................................................................................................................. 1368

501) RIFALAZIL ............................................................................................................................... 1370


Summary ....................................................................................................................................... 1370

Originators ..................................................................................................................................... 1371


Clinical Data: .................................................................................................................................. 1371

502) RIFAMYCIN ............................................................................................................................. 1373

Summary ....................................................................................................................................... 1373

Originators ..................................................................................................................................... 1373


Clinical Data: .................................................................................................................................. 1373

503) RIOCIGUAT ............................................................................................................................. 1375

Summary ....................................................................................................................................... 1376

Originators ..................................................................................................................................... 1376


Clinical Data: .................................................................................................................................. 1376

504) RIVOGLITAZONE .................................................................................................................... 1378

Summary ....................................................................................................................................... 1378

Originators ..................................................................................................................................... 1378


Clinical Data: .................................................................................................................................. 1379

505) ROFLUMILAST ........................................................................................................................ 1381

Summary ....................................................................................................................................... 1381

Originators ..................................................................................................................................... 1381


Clinical Data: .................................................................................................................................. 1381

506) ROLOFYLLINE ......................................................................................................................... 1383

Summary ....................................................................................................................................... 1383

Originators ..................................................................................................................................... 1384


Clinical Data: .................................................................................................................................. 1384

507) ROSUVASTATIN + ABT-335 .................................................................................................... 1386

Summary ....................................................................................................................................... 1386

Originators ..................................................................................................................................... 1386



Clinical Data: .................................................................................................................................. 1386

508) RUBOXISTAURIN MESYLATE .................................................................................................. 1388

Summary ....................................................................................................................................... 1389

Originators ..................................................................................................................................... 1389


Clinical Data: .................................................................................................................................. 1389

509) RUSALATIDE ACETATE ........................................................................................................... 1391

Summary ....................................................................................................................................... 1391

Originators ..................................................................................................................................... 1391


Clinical Data: .................................................................................................................................. 1392

510) S-102-R .................................................................................................................................. 1394

Summary ....................................................................................................................................... 1394

Originators ..................................................................................................................................... 1394


Clinical Data: .................................................................................................................................. 1394

511) S-18886 .................................................................................................................................. 1396

Summary ....................................................................................................................................... 1396

Originators ..................................................................................................................................... 1397


Clinical Data: .................................................................................................................................. 1397

512) S-303-M ................................................................................................................................. 1399

Summary ....................................................................................................................................... 1399

Originators ..................................................................................................................................... 1399


Clinical Data: .................................................................................................................................. 1399

513) SAFINAMIDE .......................................................................................................................... 1401

Summary ....................................................................................................................................... 1402

Originators ..................................................................................................................................... 1402


Clinical Data: .................................................................................................................................. 1402


514) SAXAGLIPTIN .......................................................................................................................... 1404

Summary ....................................................................................................................................... 1404

Originators ..................................................................................................................................... 1404


Clinical Data: .................................................................................................................................. 1405

515) SENICAPOC ............................................................................................................................ 1407

Summary ....................................................................................................................................... 1407

Originators ..................................................................................................................................... 1407


Clinical Data: .................................................................................................................................. 1407

516) SER-120 .................................................................................................................................. 1409

Summary ....................................................................................................................................... 1409

Originators ..................................................................................................................................... 1410


Clinical Data: .................................................................................................................................. 1410

517) SEVELAMER HYDROCHLORIDE .............................................................................................. 1412

Summary ....................................................................................................................................... 1412

Originators ..................................................................................................................................... 1412


Clinical Data: .................................................................................................................................. 1412

518) SH-U-555-C ............................................................................................................................ 1414

Summary ....................................................................................................................................... 1415

Originators ..................................................................................................................................... 1415


Clinical Data: .................................................................................................................................. 1415

519) SHL-04023 .............................................................................................................................. 1417

Summary ....................................................................................................................................... 1417

Originators ..................................................................................................................................... 1417


Clinical Data: .................................................................................................................................. 1418

520) SILODOSIN ............................................................................................................................. 1420

Summary ....................................................................................................................................... 1420


Originators ..................................................................................................................................... 1420


Clinical Data: .................................................................................................................................. 1420

521) SIMPLIRIX ............................................................................................................................... 1422

Summary ....................................................................................................................................... 1422

Originators ..................................................................................................................................... 1423


Clinical Data: .................................................................................................................................. 1423

522) SINUNASE .............................................................................................................................. 1425

Summary ....................................................................................................................................... 1425

Originators ..................................................................................................................................... 1425


Clinical Data: .................................................................................................................................. 1425

523) SITAMAQUINE ....................................................................................................................... 1427

Summary ....................................................................................................................................... 1428

Originators ..................................................................................................................................... 1428


Clinical Data: .................................................................................................................................. 1428

524) SITIMAGENE CERADENOVEC ................................................................................................. 1430

Summary ....................................................................................................................................... 1430

Originators ..................................................................................................................................... 1430


Clinical Data: .................................................................................................................................. 1431

525) SK-1306X ................................................................................................................................ 1433

Summary ....................................................................................................................................... 1433

Originators ..................................................................................................................................... 1433


Clinical Data: .................................................................................................................................. 1433

526) SK-3530 .................................................................................................................................. 1435

Summary ....................................................................................................................................... 1435

Originators ..................................................................................................................................... 1436



Clinical Data: .................................................................................................................................. 1436

527) SLV-308 .................................................................................................................................. 1438

Summary ....................................................................................................................................... 1438

Originators ..................................................................................................................................... 1438


Clinical Data: .................................................................................................................................. 1438

528) SODIUM HYALURONATE (TOPICAL OPHTHALMIC USE) ........................................................ 1440

Summary ....................................................................................................................................... 1441

Originators ..................................................................................................................................... 1441


Clinical Data: .................................................................................................................................. 1441

529) SODIUM OXYBATE ................................................................................................................. 1443

Summary ....................................................................................................................................... 1443

Originators ..................................................................................................................................... 1443


Clinical Data: .................................................................................................................................. 1444

530) SOH-075 ................................................................................................................................. 1446

Summary ....................................................................................................................................... 1446

Originators ..................................................................................................................................... 1446


Clinical Data: .................................................................................................................................. 1446

531) SOLUBLE BETA-1,3/1,6 GLUCAN ............................................................................................ 1448

Summary ....................................................................................................................................... 1448

Originators ..................................................................................................................................... 1449


Clinical Data: .................................................................................................................................. 1449

532) SQUALAMINE ......................................................................................................................... 1451

Summary ....................................................................................................................................... 1451

Originators ..................................................................................................................................... 1451


Clinical Data: .................................................................................................................................. 1451

533) SR-121463 .............................................................................................................................. 1453


Summary ....................................................................................................................................... 1454

Originators ..................................................................................................................................... 1454


Clinical Data: .................................................................................................................................. 1454

534) SR-58611 ................................................................................................................................ 1456

Summary ....................................................................................................................................... 1456

Originators ..................................................................................................................................... 1456


Clinical Data: .................................................................................................................................. 1457

535) SSR-591813 ............................................................................................................................ 1459

Summary ....................................................................................................................................... 1459

Originators ..................................................................................................................................... 1459


Clinical Data: .................................................................................................................................. 1459

536) STANNSOPORFIN ................................................................................................................... 1461

Summary ....................................................................................................................................... 1461

Originators ..................................................................................................................................... 1462


Clinical Data: .................................................................................................................................. 1462

537) STREPTORIX ........................................................................................................................... 1464

Summary ....................................................................................................................................... 1464

Originators ..................................................................................................................................... 1464


Clinical Data: .................................................................................................................................. 1464

538) SUBSTANCE P ANTAGONISTS (MERCK) ................................................................................. 1466

Summary ....................................................................................................................................... 1467

Originators ..................................................................................................................................... 1467


Clinical Data: .................................................................................................................................. 1467

539) SUCCINOBUCOL ..................................................................................................................... 1469

Summary ....................................................................................................................................... 1469

Originators ..................................................................................................................................... 1469



Clinical Data: .................................................................................................................................. 1470

540) SUFENTANIL IMPLANT ........................................................................................................... 1472

Summary ....................................................................................................................................... 1472

Originators ..................................................................................................................................... 1472


Clinical Data: .................................................................................................................................. 1472

541) SUMATRIPTAN (NEEDLELESS DELIVERY, INTRAJECT) ............................................................ 1474

Summary ....................................................................................................................................... 1474

Originators ..................................................................................................................................... 1475


Clinical Data: .................................................................................................................................. 1475

542) SUMATRIPTAN (SUBLINGUAL, MIGRAINE) ............................................................................ 1477

Summary ....................................................................................................................................... 1477

Originators ..................................................................................................................................... 1477


Clinical Data: .................................................................................................................................. 1477

543) SUSTAINED RELEASE RECOMBINANT HUMAN GROWTH ...................................................... 1479

Summary ....................................................................................................................................... 1480

Originators ..................................................................................................................................... 1480


Clinical Data: .................................................................................................................................. 1480

544) T4N5 LIPOSOME LOTION ....................................................................................................... 1482

Summary ....................................................................................................................................... 1482

Originators ..................................................................................................................................... 1482


Clinical Data: .................................................................................................................................. 1483

545) TACI-IG ................................................................................................................................... 1485

Summary ....................................................................................................................................... 1485

Originators ..................................................................................................................................... 1485


Clinical Data: .................................................................................................................................. 1485


546) TACROLIMUS ......................................................................................................................... 1487

Summary ....................................................................................................................................... 1487

Originators ..................................................................................................................................... 1488


Clinical Data: .................................................................................................................................. 1488

547) TAFAMIDIS ............................................................................................................................. 1490

Summary ....................................................................................................................................... 1490

Originators ..................................................................................................................................... 1490


Clinical Data: .................................................................................................................................. 1490

548) TAFENOQUINE ....................................................................................................................... 1492

Summary ....................................................................................................................................... 1493

Originators ..................................................................................................................................... 1493


Clinical Data: .................................................................................................................................. 1493

549) TAGATOSE ............................................................................................................................. 1495

Summary ....................................................................................................................................... 1495

Originators ..................................................................................................................................... 1495


Clinical Data: .................................................................................................................................. 1496

550) TAK-242 ................................................................................................................................. 1498

Summary ....................................................................................................................................... 1498

Originators ..................................................................................................................................... 1498


Clinical Data: .................................................................................................................................. 1498

551) TALACTOFERRIN .................................................................................................................... 1500

Summary ....................................................................................................................................... 1500

Originators ..................................................................................................................................... 1501


Clinical Data: .................................................................................................................................. 1501

552) TALIGLUCERASE ALFA ............................................................................................................ 1503

Summary ....................................................................................................................................... 1503


Originators ..................................................................................................................................... 1503


Clinical Data: .................................................................................................................................. 1503

553) TANESPIMYCIN ...................................................................................................................... 1505

Summary ....................................................................................................................................... 1506

Originators ..................................................................................................................................... 1506


Clinical Data: .................................................................................................................................. 1506

554) TAPENTADOL ......................................................................................................................... 1508

Summary ....................................................................................................................................... 1508

Originators ..................................................................................................................................... 1508


Clinical Data: .................................................................................................................................. 1509

555) TARIBAVIRIN .......................................................................................................................... 1511

Summary ....................................................................................................................................... 1511

Originators ..................................................................................................................................... 1511


Clinical Data: .................................................................................................................................. 1511

556) TASIMELTEON ........................................................................................................................ 1513

Summary ....................................................................................................................................... 1513

Originators ..................................................................................................................................... 1514


Clinical Data: .................................................................................................................................. 1514

557) TASPOGLUTIDE ...................................................................................................................... 1516

Summary ....................................................................................................................................... 1516

Originators ..................................................................................................................................... 1516


Clinical Data: .................................................................................................................................. 1516

558) TECADENOSON ...................................................................................................................... 1518

Summary ....................................................................................................................................... 1519

Originators ..................................................................................................................................... 1519



Clinical Data: .................................................................................................................................. 1519

559) TECTIN ................................................................................................................................... 1521

Summary ....................................................................................................................................... 1521

Originators ..................................................................................................................................... 1521


Clinical Data: .................................................................................................................................. 1522

560) TEDUGLUTIDE ........................................................................................................................ 1524

Summary ....................................................................................................................................... 1524

Originators ..................................................................................................................................... 1524


Clinical Data: .................................................................................................................................. 1524

561) TELAPREVIR ........................................................................................................................... 1526

Summary ....................................................................................................................................... 1526

Originators ..................................................................................................................................... 1527


Clinical Data: .................................................................................................................................. 1527

562) TENOFOVIR (VAGINAL GEL) ................................................................................................... 1529

Summary ....................................................................................................................................... 1529

Originators ..................................................................................................................................... 1529


Clinical Data: .................................................................................................................................. 1529

563) TEPLIZUMAB .......................................................................................................................... 1531

Summary ....................................................................................................................................... 1532

Originators ..................................................................................................................................... 1532


Clinical Data: .................................................................................................................................. 1532

564) TERBINAFINE (TOPICAL) ........................................................................................................ 1534

Summary ....................................................................................................................................... 1534

Originators ..................................................................................................................................... 1534


Clinical Data: .................................................................................................................................. 1535

565) TERIFLUNOMIDE .................................................................................................................... 1537


Summary ....................................................................................................................................... 1537

Originators ..................................................................................................................................... 1537


Clinical Data: .................................................................................................................................. 1537

566) TERLIPRESSIN ......................................................................................................................... 1539

Summary ....................................................................................................................................... 1539

Originators ..................................................................................................................................... 1540


Clinical Data: .................................................................................................................................. 1540

567) TESAMORELIN ....................................................................................................................... 1542

Summary ....................................................................................................................................... 1542

Originators ..................................................................................................................................... 1542


Clinical Data: .................................................................................................................................. 1542

568) TESMILIFENE .......................................................................................................................... 1544

Summary ....................................................................................................................................... 1545

Originators ..................................................................................................................................... 1545


Clinical Data: .................................................................................................................................. 1545

569) TESTOSTERONE ...................................................................................................................... 1547

Summary ....................................................................................................................................... 1547

Originators ..................................................................................................................................... 1547


Clinical Data: .................................................................................................................................. 1548

570) TESTOSTERONE + ESTRADIOL GEL ......................................................................................... 1550

Summary ....................................................................................................................................... 1550

Originators ..................................................................................................................................... 1550


Clinical Data: .................................................................................................................................. 1550

571) TESTOSTERONE GEL............................................................................................................... 1552

Summary ....................................................................................................................................... 1552

Originators ..................................................................................................................................... 1553



Clinical Data: .................................................................................................................................. 1553

572) TETOMILAST .......................................................................................................................... 1555

Summary ....................................................................................................................................... 1555

Originators ..................................................................................................................................... 1555


Clinical Data: .................................................................................................................................. 1555

573) TEZOSENTAN ......................................................................................................................... 1557

Summary ....................................................................................................................................... 1558

Originators ..................................................................................................................................... 1558


Clinical Data: .................................................................................................................................. 1558

574) THC + CBD .............................................................................................................................. 1560

Summary ....................................................................................................................................... 1560

Originators ..................................................................................................................................... 1560


Clinical Data: .................................................................................................................................. 1561

575) THERACLEC LIPASE ................................................................................................................ 1563

Summary ....................................................................................................................................... 1563

Originators ..................................................................................................................................... 1563


Clinical Data: .................................................................................................................................. 1563

576) THROMBIN RECEPTOR ANTAGONIST .................................................................................... 1565

Summary ....................................................................................................................................... 1565

Originators ..................................................................................................................................... 1566


Clinical Data: .................................................................................................................................. 1566

577) THYMALFASIN ........................................................................................................................ 1568

Summary ....................................................................................................................................... 1568

Originators ..................................................................................................................................... 1568


Clinical Data: .................................................................................................................................. 1568


578) THYMIDINE KINASE EXPRESSING DONOR T CELLS ................................................................ 1570

Summary ....................................................................................................................................... 1571

Originators ..................................................................................................................................... 1571


Clinical Data: .................................................................................................................................. 1571

579) TIFACOGIN ............................................................................................................................. 1573

Summary ....................................................................................................................................... 1573

Originators ..................................................................................................................................... 1573


Clinical Data: .................................................................................................................................. 1574

580) TILARGININE ACETATE ........................................................................................................... 1576

Summary ....................................................................................................................................... 1576

Originators ..................................................................................................................................... 1576


Clinical Data: .................................................................................................................................. 1576

581) TIOPRONIN ............................................................................................................................ 1578

Summary ....................................................................................................................................... 1578

Originators ..................................................................................................................................... 1579


Clinical Data: .................................................................................................................................. 1579

582) TIPIFARNIB ............................................................................................................................. 1581

Summary ....................................................................................................................................... 1581

Originators ..................................................................................................................................... 1581


Clinical Data: .................................................................................................................................. 1581

583) TIRAPAZAMINE ...................................................................................................................... 1583

Summary ....................................................................................................................................... 1584

Originators ..................................................................................................................................... 1584


Clinical Data: .................................................................................................................................. 1584

584) TIVOZANIB ............................................................................................................................. 1586

Summary ....................................................................................................................................... 1586


Originators ..................................................................................................................................... 1586


Clinical Data: .................................................................................................................................. 1587

585) TLT THERAPY .......................................................................................................................... 1589

Summary ....................................................................................................................................... 1589

Originators ..................................................................................................................................... 1589


Clinical Data: .................................................................................................................................. 1589

586) TM INJECTION SOLUTION ...................................................................................................... 1591

Summary ....................................................................................................................................... 1591

Originators ..................................................................................................................................... 1592


Clinical Data: .................................................................................................................................. 1592

587) TMC-278 + TRUVADA ............................................................................................................ 1594

Summary ....................................................................................................................................... 1594

Originators ..................................................................................................................................... 1594


Clinical Data: .................................................................................................................................. 1594

588) TNF ALPHA RECEPTOR-FC ...................................................................................................... 1596

Summary ....................................................................................................................................... 1597

Originators ..................................................................................................................................... 1597


Clinical Data: .................................................................................................................................. 1597

589) TOBRAMYCIN (INHALED) ....................................................................................................... 1599

Summary ....................................................................................................................................... 1599

Originators ..................................................................................................................................... 1599


Clinical Data: .................................................................................................................................. 1600

590) TOLEVAMER ........................................................................................................................... 1602

Summary ....................................................................................................................................... 1602

Originators ..................................................................................................................................... 1602



Clinical Data: .................................................................................................................................. 1602

591) TOPICAL CROMOLYN SODIUM .............................................................................................. 1604

Summary ....................................................................................................................................... 1604

Originators ..................................................................................................................................... 1605


Clinical Data: .................................................................................................................................. 1605

592) TOREMIFENE.......................................................................................................................... 1607

Summary ....................................................................................................................................... 1607

Originators ..................................................................................................................................... 1607


Clinical Data: .................................................................................................................................. 1607

593) TOREZOLID ............................................................................................................................. 1609

Summary ....................................................................................................................................... 1610

Originators ..................................................................................................................................... 1610


Clinical Data: .................................................................................................................................. 1610

594) TORSEMIDE ER ....................................................................................................................... 1612

Summary ....................................................................................................................................... 1612

Originators ..................................................................................................................................... 1612


Clinical Data: .................................................................................................................................. 1613

595) TRAMIPROSATE ..................................................................................................................... 1615

Summary ....................................................................................................................................... 1615

Originators ..................................................................................................................................... 1615


Clinical Data: .................................................................................................................................. 1615

596) TRANSCUTANEOUS IMMUNIZATION PATCH (DIARRHEA) .................................................... 1617

Summary ....................................................................................................................................... 1617

Originators ..................................................................................................................................... 1618


Clinical Data: .................................................................................................................................. 1618

597) TRANSDERMAL KETOPROFEN ............................................................................................... 1620


Summary ....................................................................................................................................... 1620

Originators ..................................................................................................................................... 1620


Clinical Data: .................................................................................................................................. 1620

598) TRANSMUCOSAL (BEMA) FENTANYL ..................................................................................... 1622

Summary ....................................................................................................................................... 1623

Originators ..................................................................................................................................... 1623


Clinical Data: .................................................................................................................................. 1623

599) TREMELIMUMAB ................................................................................................................... 1625

Summary ....................................................................................................................................... 1625

Originators ..................................................................................................................................... 1625


Clinical Data: .................................................................................................................................. 1626

600) TRIAMCINOLONE ACETONIDE (EYE DISEASES) ...................................................................... 1628

Summary ....................................................................................................................................... 1628

Originators ..................................................................................................................................... 1628


Clinical Data: .................................................................................................................................. 1628

601) TRIMEGESTONE ..................................................................................................................... 1630

Summary ....................................................................................................................................... 1630

Originators ..................................................................................................................................... 1631


Clinical Data: .................................................................................................................................. 1631

602) TRIMEGESTONE-ESTRADIOL PATCH ...................................................................................... 1633

Summary ....................................................................................................................................... 1633

Originators ..................................................................................................................................... 1633


Clinical Data: .................................................................................................................................. 1633

603) TRIOXOLANE .......................................................................................................................... 1635

Summary ....................................................................................................................................... 1636

Originators ..................................................................................................................................... 1636



Clinical Data: .................................................................................................................................. 1636

604) TRIOXOLANE DERIVATE ......................................................................................................... 1638

Summary ....................................................................................................................................... 1638

Originators ..................................................................................................................................... 1638


Clinical Data: .................................................................................................................................. 1639

605) TRIPLE HORMONE THERAPY ORAL CONTRACEPTIVE ............................................................ 1641

Summary ....................................................................................................................................... 1641

Originators ..................................................................................................................................... 1641


Clinical Data: .................................................................................................................................. 1641

606) TRK-820 ................................................................................................................................. 1643

Summary ....................................................................................................................................... 1643

Originators ..................................................................................................................................... 1644


Clinical Data: .................................................................................................................................. 1644

607) TROVAX.................................................................................................................................. 1646

Summary ....................................................................................................................................... 1646

Originators ..................................................................................................................................... 1646


Clinical Data: .................................................................................................................................. 1646

608) TROXACITABINE ..................................................................................................................... 1648

Summary ....................................................................................................................................... 1649

Originators ..................................................................................................................................... 1649


Clinical Data: .................................................................................................................................. 1649

609) UDENAFIL ............................................................................................................................... 1651

Summary ....................................................................................................................................... 1651

Originators ..................................................................................................................................... 1651


Clinical Data: .................................................................................................................................. 1652


610) ULTRA-PURE EPA ................................................................................................................... 1654

Summary ....................................................................................................................................... 1654

Originators ..................................................................................................................................... 1654


Clinical Data: .................................................................................................................................. 1654

611) UNFRACTIONATED HEPARIN ................................................................................................. 1656

Summary ....................................................................................................................................... 1656

Originators ..................................................................................................................................... 1657


Clinical Data: .................................................................................................................................. 1657

612) USHERCELL............................................................................................................................. 1659

Summary ....................................................................................................................................... 1659

Originators ..................................................................................................................................... 1659


Clinical Data: .................................................................................................................................. 1659

613) V-1512 ................................................................................................................................... 1661

Summary ....................................................................................................................................... 1662

Originators ..................................................................................................................................... 1662


Clinical Data: .................................................................................................................................. 1662

614) VALSPODAR ........................................................................................................................... 1664

Summary ....................................................................................................................................... 1664

Originators ..................................................................................................................................... 1664


Clinical Data: .................................................................................................................................. 1665

615) VAPREOTIDE ACETATE ........................................................................................................... 1667

Summary ....................................................................................................................................... 1667

Originators ..................................................................................................................................... 1667


Clinical Data: .................................................................................................................................. 1667

616) VARESPLADIB ......................................................................................................................... 1669

Summary ....................................................................................................................................... 1669


Originators ..................................................................................................................................... 1670


Clinical Data: .................................................................................................................................. 1670

617) VARICELLA ZOSTER VACCINE ................................................................................................. 1672

Summary ....................................................................................................................................... 1672

Originators ..................................................................................................................................... 1672


Clinical Data: .................................................................................................................................. 1672

618) VARISOLVE ............................................................................................................................. 1674

Summary ....................................................................................................................................... 1675

Originators ..................................................................................................................................... 1675


Clinical Data: .................................................................................................................................. 1675

619) VATALANIB ............................................................................................................................ 1677

Summary ....................................................................................................................................... 1677

Originators ..................................................................................................................................... 1677


Clinical Data: .................................................................................................................................. 1678

620) VB4-845 (SQUAMOUS CELL CANCER) .................................................................................... 1680

Summary ....................................................................................................................................... 1680

Originators ..................................................................................................................................... 1680


Clinical Data: .................................................................................................................................. 1680

621) VEDOLIZUMAB ....................................................................................................................... 1682

Summary ....................................................................................................................................... 1682

Originators ..................................................................................................................................... 1683


Clinical Data: .................................................................................................................................. 1683

622) VEGF GENE THERAPY ............................................................................................................. 1685

Summary ....................................................................................................................................... 1685

Originators ..................................................................................................................................... 1685



Clinical Data: .................................................................................................................................. 1685

623) VEGF TRAP ............................................................................................................................. 1687

Summary ....................................................................................................................................... 1688

Originators ..................................................................................................................................... 1688


Clinical Data: .................................................................................................................................. 1688

624) VEGF TRAP-EYE ...................................................................................................................... 1690

Summary ....................................................................................................................................... 1690

Originators ..................................................................................................................................... 1690


Clinical Data: .................................................................................................................................. 1691

625) VICRIVIROC ............................................................................................................................ 1693

Summary ....................................................................................................................................... 1693

Originators ..................................................................................................................................... 1693


Clinical Data: .................................................................................................................................. 1693

626) VINFLUNINE ........................................................................................................................... 1695

Summary ....................................................................................................................................... 1695

Originators ..................................................................................................................................... 1696


Clinical Data: .................................................................................................................................. 1696

629) VINORELBINE ......................................................................................................................... 1698

Summary ....................................................................................................................................... 1698

Originators ..................................................................................................................................... 1698


Clinical Data: .................................................................................................................................. 1698

630) VIRAMIDINE ........................................................................................................................... 1700

Summary ....................................................................................................................................... 1701

Originators ..................................................................................................................................... 1701


Clinical Data: .................................................................................................................................. 1701

631) VIRULIZIN ............................................................................................................................... 1703


Summary ....................................................................................................................................... 1703

Originators ..................................................................................................................................... 1703


Clinical Data: .................................................................................................................................. 1704

632) VITAXIN .................................................................................................................................. 1706

Summary ....................................................................................................................................... 1706

Originators ..................................................................................................................................... 1706


Clinical Data: .................................................................................................................................. 1706

633) VITREOSOLVE ......................................................................................................................... 1708

Summary ....................................................................................................................................... 1708

Originators ..................................................................................................................................... 1709


Clinical Data: .................................................................................................................................. 1709

634) VOCLOSPORIN ....................................................................................................................... 1711

Summary ....................................................................................................................................... 1711

Originators ..................................................................................................................................... 1711


Clinical Data: .................................................................................................................................. 1711

635) VRX-806 ................................................................................................................................. 1713

Summary ....................................................................................................................................... 1714

Originators ..................................................................................................................................... 1714


Clinical Data: .................................................................................................................................. 1714

636) WOUND HEALING AGENT ...................................................................................................... 1716

Summary ....................................................................................................................................... 1716

Originators ..................................................................................................................................... 1716


Clinical Data: .................................................................................................................................. 1717

637) WX-G250................................................................................................................................ 1719

Summary ....................................................................................................................................... 1719

Originators ..................................................................................................................................... 1719



Clinical Data: .................................................................................................................................. 1719

638) XEMILOFIBAN ........................................................................................................................ 1721

Summary ....................................................................................................................................... 1721

Originators ..................................................................................................................................... 1722


Clinical Data: .................................................................................................................................. 1722

639) XERECEPT ............................................................................................................................... 1724

Summary ....................................................................................................................................... 1724

Originators ..................................................................................................................................... 1724


Clinical Data: .................................................................................................................................. 1724

640) XL-184 .................................................................................................................................... 1726

Summary ....................................................................................................................................... 1727

Originators ..................................................................................................................................... 1727


Clinical Data: .................................................................................................................................. 1727

641) XRP-9881 ............................................................................................................................... 1729

Summary ....................................................................................................................................... 1729

Originators ..................................................................................................................................... 1729


Clinical Data: .................................................................................................................................. 1729

642) YY-280 .................................................................................................................................... 1731

Summary ....................................................................................................................................... 1732

Originators ..................................................................................................................................... 1732


Clinical Data: .................................................................................................................................. 1732

643) ZANOLIMUMAB ..................................................................................................................... 1734

Summary ....................................................................................................................................... 1734

Originators ..................................................................................................................................... 1734


Clinical Data: .................................................................................................................................. 1735


644) ZERENEX ................................................................................................................................ 1737

Summary ....................................................................................................................................... 1737

Originators ..................................................................................................................................... 1737


Clinical Data: .................................................................................................................................. 1737

645) ZOLMITRIPTAN ORAL DISPERSIBLE FILM ............................................................................... 1739

Summary ....................................................................................................................................... 1739

Originators ..................................................................................................................................... 1739


Clinical Data: .................................................................................................................................. 1740

646) ZURAGEN ............................................................................................................................... 1742

Summary ....................................................................................................................................... 1742

Originators ..................................................................................................................................... 1742


Clinical Data: .................................................................................................................................. 1742

647) ZYC-101A ............................................................................................................................... 1744

Summary ....................................................................................................................................... 1744

Originators ..................................................................................................................................... 1744


Clinical Data: .................................................................................................................................. 1745

CBDM.T – Market and Business Intelligence – The Company ........................................................... 1748


CBDM.T – Market and Business Intelligence – The Company

CBDMT® - THE MARKET AND BUSINESS INTELLIGENCE COMPANY

CBDMT links innovation to markets by providing solutions to better characterize:

Market Uncertainty: How large is the potential market?

Technological Uncertainty: Will new technology or innovation really make ours or others obsolete?

Competitive Volatility: What products will we compete with? Who will be the new competition in the future? What competitive tactics will be needed?

CBDMT® services:

Market Analysis Market Survey

Market Scouting Business Development

Marketing Support Strategy

Markets:

Biotechnology Pharmaceutical Industry

Bioproduction Chemical Industry

Energy LifeSciences

Feed & Food Industries

Cosmetics

France: 88-90 rue de la Mare 75020 Paris, France

Tel : +33 1 4474 7957 Fax : +33 1 7711 8459

www.cbdmt.com

At the hour of the development of new technologies and new services in the worldwide innovation

market, market and business intelligence has never been so necessary. In a globalized world where

the economic-technological war beats its drum, differentiation is a major asset. This is why, at

CBDM.T®, our job is to chart and analyze, in an objective and exhaustive way, all players and

technologies of the market in order to establish a powerful market-oriented strategy.

CBDM.T® is a market and business intelligence company with offices in France, Switzerland and

Israel. As an advisory services company, CBDM.T® boosts companies to develop revenue and growth

by providing business and marketing services in the life science and biotech markets (market surveys,

market scouting, business development and strategic supports).

CBDM.T® provides to small, medium and large companies technology-based business development

support to identify new customers and also to fine-tune a business strategy. Typically, CBDM.T®

interacts with its clients as business development or executive partners to maximize effectiveness

and minimize risks to sound out international markets (WOI - Window Opportunity Identification).

http://www.cbdmt.com/


“Copyright 2010 CBDM.T SARL - Market and Business Intelligence. All rights reserved. Any unauthorized use or disclosure is

prohibited. The information herein was obtained from various sources; we do not guarantee its accuracy or completeness.

This research report is prepared for general circulation and is circulated for general information only. It does not have

regard to specific investment objectives, financial situation and the particular needs of any particular person who may

receive this report. Investors should seek financial advice regarding the appropriateness of investing in any securities or

investment and trading strategies discussed or recommended in this report and should understand that the statements

regarding future prospects may not be realized. Investors should note that income from such securities, if any, may

fluctuate and that each security's price or value may rise or fall. Accordingly, investors may receive back less than originally

invested. Past performance is not necessarily a guide to future performance. Neither the information nor any opinion

expressed constitutes an offer to buy or sell any securities or options or futures contracts. CBDM.T - Market and Business

Intelligence accepts no responsibility or liability whatsoever for any expense, loss or damages arising out of or in any way

connected with the use of all or any part of this report. CBDM.T SARL does not have long or short position in any securities

or options of this issue(s)."

Contact: CBDM.T – Market & Business Intelligence – 75 rue de la Mare – Fr-75020 PARIS - FRANCE

Tel : + 33 1 4474 7957

http://www.cbdmt.com

http://www.cbdmt.com/

clinical phase iii product report - cbdmt market and business intelligence - toc

Documents